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    Clinical Trial Results:
    A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).

    Summary
    EudraCT number
    		 2018-003113-17
    Trial protocol
    		 GB  
    Global end of trial date
    06 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2020
    First version publication date
    23 Aug 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MEU 17/361
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03842904
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MEU number: MEU 17/361
    Sponsors
    Sponsor organisation name
    Medicines Evaluation Unit (MEU) Ltd.
    Sponsor organisation address
    The Langley Building, Southmoor Road, Manchester, United Kingdom, M23 9QZ
    Public contact
    Paul Strelow, The Medicines Evaluation Unit (MEU) Ltd., 0044 0161 946 4050, pstrelow@meu.org.uk
    Scientific contact
    Professor Dave Singh, The Medicines Evaluation Unit (MEU) Ltd., 0044 0161 946 4050, enquiries@meu.org.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To compare the effect of Trimbow and Fostair on FEV1 [(forced expiratory volume in 1 second – changes from pre-dose day 1)]. 2) To compare the effect of Trimbow and Fostair on RV [(residual volume) – changes from pre-dose day 1)].
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements . Trained medical staff, necessary equipment and appropriate medication were available at the clinic, or at the nearby hospital, in case of any emergencies. Safety assessments (e.g. vital signs, ECGs, physical examinations and safety laboratory samples) were performed prior to enrolment into the study. Vital signs and physical examinations were performed regularly to ensure the health and safety of trial subjects.
    Background therapy
    		 Salbutamol (metered-dose inhaler pMDI) was provided to all subjects as rescue medication for as-needed use any time during the study. At the investigator’s discretion it could be regularly taken during the run-in and washout periods, if for example a subject was withdrawing from a long-acting β2-agonist. However, it could not be used up to 8 hours before each study centre visit or, during study centre visits with lung function procedures unless medically necessary. Subjects withdrawing from a long-acting muscarinic antagonist could use the provided short-acting anticholinergic ipratropium regularly (40 μg, up to 3 times a day) during the run-in and washout periods, at the discretion of the investigator. However, it could not be used for at least 8 hours before spirometry assessments at Visit 1, Visit 2 and Day 1 of either treatment period or during each treatment period (Day 1 to Day 5). During the run-in and washout periods and after screening spirometry criteria were met, subjects switched to supplied background corticosteroid monotherapy Clenil (R) Modulite(R) beclometasone dipropionate (400 μg daily: 2 × 100 μg pMDI doses twice daily [BID]) omitting the morning dose on Visit 2 and Day 1 of each treatment period. Hormonal contraception or hormone replacement therapy and medications that the investigator considered would not compromise subject safety or affect study data were permitted (unless listed as not permitted below).
    Evidence for comparator
    		 The study drugs called Trimbow and Fostair are licensed medications for the treatment of chronic obstructive pulmonary disease (COPD). The most commonly used treatments for COPD are inhaled bronchodilators (beta agonists and muscarinic antagonists) which open up the airways and inhaled steroids which reduce inflammation of the airways. Trimbow is a triple combination pressurised metered dose inhaler (pMDI) containing a steroid (called beclometasone diproprionate), a long acting beta agonist (called formoterol fumarate) and a long acting antagonist (called glycopyrronium bromide), which has shown to improve lung function and reduce COPD exacerbation (worsening) rates. Fostair is a dual combination pMDI containing the same steroid and long acting beta agonist that are found in Trimbow. Trimbow is an “extrafine” formulation with increased delivery of small particles to the peripheral airways. This has the advantage of targeted delivery to the anatomical site of pathophysiological abnormalities. The study investigated the contributions of extra-fine glycopyrronium and formoterol (within triple therapy) to improvements in small airway function in COPD patients. This was achieved by recruiting patients with hyperinflation, and measuring improvements in hyperinflation and expiratory flow limitation as measurements of small airway disease. The purpose of the study was to help understand the mechanisms of action of the bronchodilators within Trimbow, and potentially encourage treatment of small airway disease in COPD with extra-fine bronchodilator treatments.
    Actual start date of recruitment
    13 Dec 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    11
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was consented on 13 December 2018. 23 subjects were randomised, 22 of which completed the study. 1 subject was withdrawn during treatment period 1 due to non-compliance with the study medication.

    Pre-assignment
    Screening details
    		 Overall, 66 subjects were screened for the study. The main reason for screen failure was that subjects didn't meet inclusion criterion 7 i.e. residual volume at screening or baseline was less than or equal to 120% of their predicted value.

    Period 1
    Period 1 title
    Baseline visit
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open-label

    Arms
    Arm title
    		 Baseline (Visit 2)
    Arm description
    		 Participants entered a run-in period after screening and received a supply of Clenil Modulite Beclometasone Diproprionate to administer 2 inhalations, twice daily. Visit 2 (Baseline) was conducted 10 days after the start of the run-in period. The dose of beclometasone was administered on the morning of Visit 2 at the research unit.
    Arm type
    		 Run-in

    Investigational medicinal product name
    Clenil Modulite 100 micrograms
    Investigational medicinal product code
    Non-IMP
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily dosing after screening (2 inhalations per dose) until Day -1. 100μg per inhalation, 2 inhalations BID (total daily metered dose: 400μg).

    Number of subjects in period 1
    		Baseline (Visit 2)
    Started
    23
    Completed
    23
    Period 2
    Period 2 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The study was open-label

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Test Treatment 1
    Arm description
    		 Participants received Trimbow (Beclometasone/Formoterol/Glycopyrronium) twice daily for 4 consecutive days - two inhalations in the morning and two in the evening administered via pressurized metered dose inhaler (pMDI). After the morning dose on Day 1, subjects received a supply of study medication to take home and administer themselves. The last dose administration was on the morning of Day 5 at the research unit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
    Investigational medicinal product code
    Other name
    Beclometasone/Formoterol/Glycopyrronium
    Pharmaceutical forms
    Pressurised inhalation, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily dosing on Days 1 - 4 (2 inhalations per dose). Last dose taken on the morning of Day 5. Administered via pMDI. Total daily metered dose: 400 µg (beclometasone)/24 µg (formoterol)/40 µg (glycopyrronium). Delivered dose: 348/20/36 µg

    Arm title
    		 Test Treatment 2
    Arm description
    		 Participants received Fostair (Beclometasone/Formoterol) twice daily for 4 consecutive days - two inhalations in the morning and two in the evening administered via pressurized metered dose inhaler (pMDI). After the morning dose on Day 1, subjects received a supply of study medication to take home and administer themselves. The last dose administration was on the morning of Day 5 at the research unit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fostair 100/6 micrograms per actuation pressurised inhalation solution
    Investigational medicinal product code
    Other name
    Beclometasone/Formoterol
    Pharmaceutical forms
    Pressurised inhalation, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily dosing on Days 1 - 4 (2 inhalations per dose). Last dose taken on the morning of Day 5. Administered via pMDI. Total daily metered dose: 400 µg (beclometasone)/24 µg (formoterol).

    Number of subjects in period 2
    		Test Treatment 1 Test Treatment 2
    Started
    23
    22
    Completed
    22
    22
    Not completed
    1
    0
         non-compliance
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline visit
    Reporting group description
    		 -

    Reporting group values
    		 Baseline visit Total
    Number of subjects
    		 23 23
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 66 (48 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 9 9
    Ethnic Origin
    Units: Subjects
        Caucasian
    		 23 23
        Black
    		 0 0
        North-East Asian
    		 0 0
        South-East Asian
    		 0 0
        Other
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Baseline (Visit 2)
    Reporting group description
    		 Participants entered a run-in period after screening and received a supply of Clenil Modulite Beclometasone Diproprionate to administer 2 inhalations, twice daily. Visit 2 (Baseline) was conducted 10 days after the start of the run-in period. The dose of beclometasone was administered on the morning of Visit 2 at the research unit.
    Reporting group title
    Test Treatment 1
    Reporting group description
    		 Participants received Trimbow (Beclometasone/Formoterol/Glycopyrronium) twice daily for 4 consecutive days - two inhalations in the morning and two in the evening administered via pressurized metered dose inhaler (pMDI). After the morning dose on Day 1, subjects received a supply of study medication to take home and administer themselves. The last dose administration was on the morning of Day 5 at the research unit.

    Reporting group title
    Test Treatment 2
    Reporting group description
    		 Participants received Fostair (Beclometasone/Formoterol) twice daily for 4 consecutive days - two inhalations in the morning and two in the evening administered via pressurized metered dose inhaler (pMDI). After the morning dose on Day 1, subjects received a supply of study medication to take home and administer themselves. The last dose administration was on the morning of Day 5 at the research unit.

    Primary: FEV1 AUC0-12 Response at Day 5

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    End point title
    		 FEV1 AUC0-12 Response at Day 5
    End point description
    To compare the FEV1 area under the curve response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.333 ( 0.0372 )
    0.229 ( 0.0372 )
    Statistical analysis title
    		 FEV1 AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0071
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.104
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.037
         upper limit
    		 0.171
    Variability estimate
    Standard error of the mean

    Primary: Peak FEV1 Response at Day 5

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    End point title
    		 Peak FEV1 Response at Day 5
    End point description
    To compare the peak FEV1 response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.503 ( 0.0454 )
    0.384 ( 0.0454 )
    Statistical analysis title
    		 Peak FEV1 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0016
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.055
         upper limit
    		 0.184
    Variability estimate
    Standard error of the mean

    Primary: Pre-dose Trough FEV1 Response at Day 5

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    End point title
    		 Pre-dose Trough FEV1 Response at Day 5
    End point description
    To compare the pre-dose trough FEV1 response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Prior to the subject dosing on Day 5.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.243 ( 0.0333 )
    0.134 ( 0.0333 )
    Statistical analysis title
    		 Pre-dose Trough FEV1 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0126
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.109
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.026
         upper limit
    		 0.191
    Variability estimate
    Standard error of the mean

    Primary: Post-dose Trough FEV1 Response at Day 5

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    End point title
    		 Post-dose Trough FEV1 Response at Day 5
    End point description
    To compare the post-dose trough FEV1 response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    12 hours after subject dosing is complete on Day 5.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.175 ( 0.0291 )
    0.109 ( 0.0291 )
    Statistical analysis title
    		 Post-dose Trough FEV1 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0797
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.065
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.009
         upper limit
    		 0.139
    Variability estimate
    Standard error of the mean

    Primary: RV AUC0-12 Response at Day 5

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    End point title
    		 RV AUC0-12 Response at Day 5
    End point description
    To compare the RV area under the curve response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.696 ( 0.0750 )
    -0.532 ( 0.0750 )
    Statistical analysis title
    		 RV AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0028
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.163
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.263
         upper limit
    		 -0.064
    Variability estimate
    Standard error of the mean

    Primary: Peak RV Response at Day 5

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    End point title
    		 Peak RV Response at Day 5
    End point description
    To compare the peak RV response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.947 ( 0.0873 )
    -0.869 ( 0.0873 )
    Statistical analysis title
    		 Peak RV Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1092
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.079
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.176
         upper limit
    		 0.019
    Variability estimate
    Standard error of the mean

    Primary: Pre-dose Trough RV Response at Day 5

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    End point title
    		 Pre-dose Trough RV Response at Day 5
    End point description
    To compare the pre-dose trough RV response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    Prior to the subject dosing on Day 5.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.531 ( 0.0723 )
    -0.360 ( 0.0723 )
    Statistical analysis title
    		 Pre-dose Trough RV Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0331
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.171
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.327
         upper limit
    		 -0.015
    Variability estimate
    Standard error of the mean

    Primary: Post-dose Trough RV Response at Day 5

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    End point title
    		 Post-dose Trough RV Response at Day 5
    End point description
    To compare the post-dose trough RV response at Day 5 between the 2 treatments.
    End point type
    Primary
    End point timeframe
    12 hours after subject dosing is complete on Day 5.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.446 ( 0.0749 )
    -0.268 ( 0.0749 )
    Statistical analysis title
    		 Post-dose Trough RV Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0097
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.179
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.308
         upper limit
    		 -0.049
    Variability estimate
    Standard error of the mean

    Secondary: Spirometry parameters AUC0-12 Response at Day 5 (FEF)

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    End point title
    		 Spirometry parameters AUC0-12 Response at Day 5 (FEF)
    End point description
    To compare the FEF area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: L/s
        least squares mean (standard error)
    0.110 ( 0.0160 )
    0.083 ( 0.0160 )
    Statistical analysis title
    		 Spirometry Parameters AUC0-12 Response at Day 5
    Statistical analysis description
    FEF 25-75% (L/s)
    Comparison groups
    Test Treatment 2 v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0395
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.001
         upper limit
    		 0.051
    Variability estimate
    Standard error of the mean

    Secondary: Spirometry parameters AUC0-12 Response at Day 5(FVC)

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    End point title
    		 Spirometry parameters AUC0-12 Response at Day 5(FVC)
    End point description
    To compare the FVC area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.545 ( 0.0642 )
    0.339 ( 0.0642 )
    Statistical analysis title
    		 Spirometry Parameters AUC0-12 Response at Day 5
    Statistical analysis description
    FVC (L)
    Comparison groups
    Test Treatment 2 v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0116
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.206
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.054
         upper limit
    		 0.359
    Variability estimate
    Standard error of the mean

    Secondary: Spirometry Parameters Peak Response at Day 5 (FEF)

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    End point title
    		 Spirometry Parameters Peak Response at Day 5 (FEF)
    End point description
    To compare the peak FEF response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: L/s
        least squares mean (standard error)
    0.210 ( 0.0271 )
    0.166 ( 0.0271 )
    Statistical analysis title
    		 Spirometry Parameters Peak Response at Day 5 (ITT)
    Statistical analysis description
    FEF 25-75% (L/s)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0442
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.044
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.001
         upper limit
    		 0.088
    Variability estimate
    Standard error of the mean

    Secondary: Spirometry Parameters Peak Response at Day 5 (FVC)

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    End point title
    		 Spirometry Parameters Peak Response at Day 5 (FVC)
    End point description
    To compare the peak FVC response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.850 ( 0.0919 )
    0.607 ( 0.0919 )
    Statistical analysis title
    		 Spirometry Parameters Peak Response at Day 5 (ITT)
    Statistical analysis description
    FVC (L)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0106
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.243
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.068
         upper limit
    		 0.419
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (AX)

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    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (AX)
    End point description
    To compare the AX area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L
        least squares mean (standard error)
    -2.911 ( 0.2668 )
    -2.205 ( 0.2668 )
    Statistical analysis title
    		 AX AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0004
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.706
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.047
         upper limit
    		 -0.365
    Variability estimate
    Standard deviation

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (Delta X5)

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    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (Delta X5)
    End point description
    To compare the Delta X5 area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.137 ( 0.0387 )
    -0.095 ( 0.0387 )
    Statistical analysis title
    		 Delta X5 AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0575
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.042
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.086
         upper limit
    		 0.002
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (Fres)

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    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (Fres)
    End point description
    To compare the Fres area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: 1/s
        least squares mean (standard error)
    -7.201 ( 0.9146 )
    -5.005 ( 0.9146 )
    Statistical analysis title
    		 Fres AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0016
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.195
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.451
         upper limit
    		 -0.94
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (R5)

    		 Close Top of page
    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (R5)
    End point description
    To compare the R5 area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.186 ( 0.0179 )
    -0.131 ( 0.0179 )
    Statistical analysis title
    		 R5 AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0005
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    -0.055
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.082
         upper limit
    		 -0.028
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (R5-R20)

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    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (R5-R20)
    End point description
    To compare the R5-R20 area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.163 ( 0.0154 )
    -0.118 ( 0.0154 )
    Statistical analysis title
    		 R5-R20 AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0002
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.045
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.065
         upper limit
    		 -0.025
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (X5)

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    End point title
    		 Impulse Oscillometry Parameters AUC0-12 Response at Day 5 (X5)
    End point description
    To compare the X5 area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.203 ( 0.0231 )
    0.156 ( 0.0231 )
    Statistical analysis title
    		 X5 AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0003
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.047
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.025
         upper limit
    		 0.069
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (AX)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (AX)
    End point description
    To compare the peak AX response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L
        least squares mean (standard error)
    -3.770 ( 0.2403 )
    -3.228 ( 0.2403 )
    Statistical analysis title
    		 AX Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0072
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.542
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.918
         upper limit
    		 -0.166
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (Delta X5)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (Delta X5)
    End point description
    To compare the peak Delta X5 response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.240 ( 0.0290 )
    -0.210 ( 0.0290 )
    Statistical analysis title
    		 Delta X5 Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2892
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.088
         upper limit
    		 0.028
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (Fres)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (Fres)
    End point description
    To compare the peak Fres response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: 1/s
        least squares mean (standard error)
    -11.130 ( 1.0881 )
    -8.613 ( 1.0881 )
    Statistical analysis title
    		 Fres Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0007
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.517
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.83
         upper limit
    		 -1.205
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (R5)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (R5)
    End point description
    To compare the peak R5 response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.258 ( 0.0183 )
    -0.211 ( 0.0183 )
    Statistical analysis title
    		 R5 Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0023
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.047
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.075
         upper limit
    		 -0.019
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (R5-R20)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (R5-R20)
    End point description
    To compare the peak R5-R20 response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.221 ( 0.0159 )
    -0.185 ( 0.0159 )
    Statistical analysis title
    		 R5-R20 Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0022
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.057
         upper limit
    		 -0.015
    Variability estimate
    Standard error of the mean

    Secondary: Impulse Oscillometry Parameters Peak Response at Day 5 (X5)

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    End point title
    		 Impulse Oscillometry Parameters Peak Response at Day 5 (X5)
    End point description
    To compare the peak X5 response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.266 ( 0.0197 )
    0.231 ( 0.0197 )
    Statistical analysis title
    		 X5 Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0355
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.003
         upper limit
    		 0.068
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (FRC)

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    End point title
    		 Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (FRC)
    End point description
    To compare the FRC area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.490 ( 0.0688 )
    -0.387 ( 0.0688 )
    Statistical analysis title
    		 FRC AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 2 v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.073
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.103
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.217
         upper limit
    		 0.011
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (IC)

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    End point title
    		 Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (IC)
    End point description
    To compare the IC area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.257 ( 0.0599 )
    0.260 ( 0.0599 )
    Statistical analysis title
    		 IC AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.9635
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.003
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.146
         upper limit
    		 0.139
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (Raw)

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    End point title
    		 Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (Raw)
    End point description
    To compare the Raw area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.279 ( 0.0204 )
    -0.222 ( 0.0204 )
    Statistical analysis title
    		 Raw AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.057
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.077
         upper limit
    		 -0.037
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (sGaw)

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    End point title
    		 Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (sGaw)
    End point description
    To compare the sGaw area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s/L
        least squares mean (standard error)
    0.311 ( 0.0328 )
    0.213 ( 0.0328 )
    Statistical analysis title
    		 sGaw AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0101
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.099
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.031
         upper limit
    		 0.167
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (TLC)

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    End point title
    		 Whole Body Plethysmography Parameters AUC0-12 Response at Day 5 (TLC)
    End point description
    To compare the TLC area under the curve response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.218 ( 0.0497 )
    -0.137 ( 0.0497 )
    Statistical analysis title
    		 TLC AUC0-12 Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1585
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.081
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.196
         upper limit
    		 0.034
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters Peak Response at Day 5 (FRC)

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    End point title
    		 Whole Body Plethysmography Parameters Peak Response at Day 5 (FRC)
    End point description
    To compare the peak FRC response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.713 ( 0.0855 )
    -0.660 ( 0.0855 )
    Statistical analysis title
    		 FRC Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2934
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.053
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.156
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters Peak Response at Day 5 (IC)

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    End point title
    		 Whole Body Plethysmography Parameters Peak Response at Day 5 (IC)
    End point description
    To compare the peak IC response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.458 ( 0.0795 )
    0.470 ( 0.0795 )
    Statistical analysis title
    		 IC Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8703
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.169
         upper limit
    		 0.145
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters Peak Response at Day 5 (Raw)

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    End point title
    		 Whole Body Plethysmography Parameters Peak Response at Day 5 (Raw)
    End point description
    To compare the peak Raw response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.351 ( 0.0175 )
    -0.309 ( 0.0175 )
    Statistical analysis title
    		 Raw Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0045
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.042
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.069
         upper limit
    		 -0.015
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters Peak Response at Day 5 (sGaw)

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    End point title
    		 Whole Body Plethysmography Parameters Peak Response at Day 5 (sGaw)
    End point description
    To compare the peak sGaw response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s/L
        least squares mean (standard error)
    0.466 ( 0.0477 )
    0.365 ( 0.0477 )
    Statistical analysis title
    		 sGaw Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0335
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.101
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.009
         upper limit
    		 0.193
    Variability estimate
    Standard error of the mean

    Secondary: Whole Body Plethysmography Parameters Peak Response at Day 5 (TLC)

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    End point title
    		 Whole Body Plethysmography Parameters Peak Response at Day 5 (TLC)
    End point description
    To compare the peak TLC response at Day 5 between the 2 treatment groups.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 of each treatment period.
    End point values
    		 Test Treatment 1 Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.391 ( 0.0508 )
    -0.306 ( 0.0508 )
    Statistical analysis title
    		 TLC Peak Response at Day 5 (ITT)
    Comparison groups
    Test Treatment 1 v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0902
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.085
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.184
         upper limit
    		 0.015
    Variability estimate
    Standard error of the mean

    Secondary: FEV1 AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 FEV1 AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the FEV1 area under the curve response between baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at baseline and on Day 5.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.003 ( 0.0320 )
    0.324 ( 0.0320 )
    Statistical analysis title
    		 FEV1 AUC0-12 Response Compared to Baseline Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.257
         upper limit
    		 0.384
    Variability estimate
    Standard error of the mean

    Secondary: FEV1 AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 FEV1 AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the FEV1 area under the curve response between baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at baseline and on Day 5.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.003 ( 0.0320 )
    0.230 ( 0.0320 )
    Statistical analysis title
    		 FEV1 AUC0-12 Response Compared to Baseline Fostair
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.227
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.163
         upper limit
    		 0.29
    Variability estimate
    Standard error of the mean

    Secondary: Peak FEV1 Response Compared to Baseline (Trimbow)

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    End point title
    		 Peak FEV1 Response Compared to Baseline (Trimbow)
    End point description
    To compare the peak FEV1 response between Baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at Baseline and on Day 5.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.092 ( 0.0414 )
    0.494 ( 0.0414 )
    Statistical analysis title
    		 Peak FEV1 Response Compared to Baseline - Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.402
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.326
         upper limit
    		 0.478
    Variability estimate
    Standard error of the mean

    Secondary: Peak FEV1 Response Compared to Baseline (Fostair)

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    End point title
    		 Peak FEV1 Response Compared to Baseline (Fostair)
    End point description
    To compare the peak FEV1 response between Baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at Baseline and on Day 5.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.092 ( 0.0414 )
    0.385 ( 0.0414 )
    Statistical analysis title
    		 Peak FEV1 Response Compared to Baseline - Fostair
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.293
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.217
         upper limit
    		 0.369
    Variability estimate
    Standard error of the mean

    Secondary: RV AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 RV AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the RV area under the curve response between baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at baseline and on Day 5 of the Treatment Period.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.047 ( 0.0689 )
    -0.725 ( 0.0689 )
    Statistical analysis title
    		 RV AUC0-12 Response Compared to Baseline (Trimbow)
    Comparison groups
    Test Treatment 1 v Baseline (Visit 2)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.678
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.847
         upper limit
    		 -0.509
    Variability estimate
    Standard error of the mean

    Secondary: RV AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 RV AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the RV area under the curve response between baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at baseline and on Day 5 of the Treatment Period
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.047 ( 0.0689 )
    -0.605 ( 0.0689 )
    Statistical analysis title
    		 RV AUC0-12 Response Compared to Baseline (Fostair)
    Comparison groups
    Test Treatment 2 v Baseline (Visit 2)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.558
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.727
         upper limit
    		 -0.389
    Variability estimate
    Standard error of the mean

    Secondary: Peak RV Response Compared to baseline (Trimbow)

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    End point title
    		 Peak RV Response Compared to baseline (Trimbow)
    End point description
    To compare the peak RV response between Baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at Baseline and on Day 5
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.276 ( 0.0821 )
    -0.981 ( 0.0821 )
    Statistical analysis title
    		 Peak RV Response Compared to Baseline - Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.705
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.915
         upper limit
    		 -0.495
    Variability estimate
    Standard error of the mean

    Secondary: Peak RV Response Compared to Baseline - Fostair

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    End point title
    		 Peak RV Response Compared to Baseline - Fostair
    End point description
    To compare the peak RV response between Baseline and Day 5.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment at Baseline and on Day 5.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.276 ( 0.0821 )
    -0.938 ( 0.0821 )
    Statistical analysis title
    		 Peak RV Response Compared to Baseline - Fostair
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.662
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.873
         upper limit
    		 -0.452
    Variability estimate
    Standard error of the mean

    Secondary: FEF Spirometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 FEF Spirometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the FEF area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: L/s
        least squares mean (standard error)
    0.001 ( 0.0156 )
    0.113 ( 0.0156 )
    Statistical analysis title
    		 FEF AUC0-12 Response Compared to baseline, Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.112
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 0.144
    Variability estimate
    Standard error of the mean

    Secondary: FEF Spirometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 FEF Spirometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the FEF area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: L/s
        least squares mean (standard error)
    0.001 ( 0.0156 )
    0.083 ( 0.0156 )
    Statistical analysis title
    		 FEF AUC0-12 Response Compared toBaseline (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.082
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.113
    Variability estimate
    Standard error of the mean

    Secondary: FVC Spirometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 FVC Spirometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the FVC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.041 ( 0.0562 )
    0.564 ( 0.0562 )
    Statistical analysis title
    		 FVC AUC0-12 Response Compared toBaseline, Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.524
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.627
    Variability estimate
    Standard error of the mean

    Secondary: FVC Spirometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 FVC Spirometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the FVC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.041 ( 0.0562 )
    0.392 ( 0.0562 )
    Statistical analysis title
    		 FVC AUC0-12 Response Compared to Baseline, Fostair
    Comparison groups
    Test Treatment 2 v Baseline (Visit 2)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.351
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.248
         upper limit
    		 0.455
    Variability estimate
    Standard error of the mean

    Secondary: AX Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 AX Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the AX area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L
        least squares mean (standard error)
    -0.348 ( 0.2831 )
    -3.339 ( 0.2831 )
    Statistical analysis title
    		 AX AUC0-12 Response Compared to Baseline (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.991
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.614
         upper limit
    		 -2.368
    Variability estimate
    Standard error of the mean

    Secondary: AX Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 AX Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the AX area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L
        least squares mean (standard error)
    -0.348 ( 0.2831 )
    -2.576 ( 0.2831 )
    Statistical analysis title
    		 AX AUC0-12 Response Compared to Baseline (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.228
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.851
         upper limit
    		 -1.604
    Variability estimate
    Standard error of the mean

    Secondary: Delta X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 Delta X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the Delta X5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.032 ( 0.0299 )
    -0.240 ( 0.0299 )
    Statistical analysis title
    		 Delta X5 AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.207
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.262
         upper limit
    		 -0.152
    Variability estimate
    Standard error of the mean

    Secondary: Delta X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 Delta X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the Delta X5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.032 ( 0.0299 )
    -0.173 ( 0.0299 )
    Statistical analysis title
    		 Delta X5 AUC0-12 Response Compared With Baseline
    Statistical analysis description
    (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.195
         upper limit
    		 -0.085
    Variability estimate
    Standard error of the mean

    Secondary: Fres Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 Fres Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the Fres area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: 1/s
        least squares mean (standard error)
    -0.366 ( 0.9547 )
    -8.602 ( 0.9547 )
    Statistical analysis title
    		 Fres AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.235
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.108
         upper limit
    		 -6.363
    Variability estimate
    Standard error of the mean

    Secondary: Fres Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 Fres Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the Fres area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: 1/s
        least squares mean (standard error)
    -0.366 ( 0.9547 )
    -5.966 ( 0.9547 )
    Statistical analysis title
    		 Fres AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.472
         upper limit
    		 -3.727
    Variability estimate
    Standard error of the mean

    Secondary: R5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 R5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the R5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.030 ( 0.0170 )
    -0.219 ( 0.0170 )
    Statistical analysis title
    		 R5 AUC0-12 Response Compared to Baseline (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.189
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.228
         upper limit
    		 -0.15
    Variability estimate
    Standard error of the mean

    Secondary: R5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 R5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the R5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.030 ( 0.0170 )
    -0.162 ( 0.0170 )
    Statistical analysis title
    		 R5 AUC0-12 Response Compared to Baseline (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.132
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.171
         upper limit
    		 -0.093
    Variability estimate
    Standard error of the mean

    Secondary: R5-R20 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 R5-R20 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the R5-R20 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.017 ( 0.0155 )
    -0.183 ( 0.0155 )
    Statistical analysis title
    		 R5-R20 AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.165
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.198
         upper limit
    		 -0.132
    Variability estimate
    Standard error of the mean

    Secondary: R5-R20 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 R5-R20 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the R5-R20 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    -0.017 ( 0.0155 )
    -0.135 ( 0.0155 )
    Statistical analysis title
    		 R5-R20 AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.117
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 -0.084
    Variability estimate
    Standard error of the mean

    Secondary: X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the X5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.034 ( 0.0210 )
    0.242 ( 0.0210 )
    Statistical analysis title
    		 X5 AUC0-12 Response Compared to Baseline (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.208
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.169
         upper limit
    		 0.248
    Variability estimate
    Standard error of the mean

    Secondary: X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 X5 Impulse Oscillometry Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the X5 area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.034 ( 0.0210 )
    0.193 ( 0.0210 )
    Statistical analysis title
    		 X5 AUC0-12 Response Compared to Baseline (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.159
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 0.198
    Variability estimate
    Standard error of the mean

    Secondary: FRC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 FRC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the FRC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.001 ( 0.0598 )
    -0.467 ( 0.0598 )
    Statistical analysis title
    		 FRC AUC0-12 Response Compared to Baseline, Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.468
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.612
         upper limit
    		 -0.323
    Variability estimate
    Standard error of the mean

    Secondary: FRC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 FRC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the FRC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    0.001 ( 0.0598 )
    -0.425 ( 0.0598 )
    Statistical analysis title
    		 FRC AUC0-12 Response Compared to Baseline, Fostair
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.426
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.571
         upper limit
    		 -0.282
    Variability estimate
    Standard error of the mean

    Secondary: IC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 IC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the IC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.071 ( 0.0507 )
    0.257 ( 0.0507 )
    Statistical analysis title
    		 IC AUC0-12 Response Compared to Baseline (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.328
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.219
         upper limit
    		 0.438
    Variability estimate
    Standard error of the mean

    Secondary: IC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 IC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the IC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.071 ( 0.0507 )
    0.218 ( 0.0507 )
    Statistical analysis title
    		 IC AUC0-12 Response Compared to Baseline (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.289
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 0.399
    Variability estimate
    Standard error of the mean

    Secondary: Raw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 Raw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the Raw area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.017 ( 0.0253 )
    -0.281 ( 0.0253 )
    Statistical analysis title
    		 Raw AUC0-12 Response Compared to Baseline, Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.298
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.369
         upper limit
    		 -0.226
    Variability estimate
    Standard error of the mean

    Secondary: Raw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 Raw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the Raw area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s
        least squares mean (standard error)
    0.017 ( 0.0253 )
    -0.225 ( 0.0253 )
    Statistical analysis title
    		 Raw AUC0-12 Response Compared to Baseline, Fostair
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.242
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.313
         upper limit
    		 -0.17
    Variability estimate
    Standard error of the mean

    Secondary: sGaw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 sGaw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the sGaw area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: kPa/L/s/L
        least squares mean (standard error)
    -0.003 ( 0.0252 )
    0.307 ( 0.0252 )
    Statistical analysis title
    		 sGaw AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Trimbow)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.259
         upper limit
    		 0.362
    Variability estimate
    Standard error of the mean

    Secondary: sGaw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 sGaw Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the sGaw area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: kPa/L/s/L
        least squares mean (standard error)
    -0.003 ( 0.0252 )
    0.221 ( 0.0252 )
    Statistical analysis title
    		 sGaw AUC0-12 Response Compared to Baseline
    Statistical analysis description
    (Fostair)
    Comparison groups
    Baseline (Visit 2) v Test Treatment 2
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.224
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.172
         upper limit
    		 0.275
    Variability estimate
    Standard error of the mean

    Secondary: TLC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)

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    End point title
    		 TLC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Trimbow)
    End point description
    To compare the TLC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 1
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.064 ( 0.0465 )
    -0.200 ( 0.0465 )
    Statistical analysis title
    		 TLC AUC0-12 Response Compared to Baseline, Trimbow
    Comparison groups
    Baseline (Visit 2) v Test Treatment 1
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0144
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.136
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.243
         upper limit
    		 -0.028
    Variability estimate
    Standard error of the mean

    Secondary: TLC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)

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    End point title
    		 TLC Whole Body Plethysmography Parameters AUC0-12 Response Compared to Baseline (Fostair)
    End point description
    To compare the TLC area under the curve response between Day 5 and baseline.
    End point type
    Secondary
    End point timeframe
    Over 12 hours after treatment on Day 5 and at baseline.
    End point values
    		 Baseline (Visit 2) Test Treatment 2
    Number of subjects analysed
    22
    22
    Units: litre(s)
        least squares mean (standard error)
    -0.064 ( 0.0465 )
    -0.196 ( 0.0465 )
    Statistical analysis title
    		 TLC AUC0-12 Response Compared to Baseline, Fostair
    Comparison groups
    Test Treatment 2 v Baseline (Visit 2)
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0174
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.132
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.239
         upper limit
    		 -0.024
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The recording period for Adverse Events is the period starting from the Informed Consent signature, until last scheduled telephone follow up call.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Trimbow 87 micrograms/5 micrograms/9 micrograms
    Reporting group description
    		 -

    Reporting group title
    Fostair 100/6 micrograms
    Reporting group description
    		 -

    Serious adverse events
    		 Trimbow 87 micrograms/5 micrograms/9 micrograms Fostair 100/6 micrograms
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Trimbow 87 micrograms/5 micrograms/9 micrograms Fostair 100/6 micrograms
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 23 (13.04%)
    7 / 22 (31.82%)
    Surgical and medical procedures
    Papilloma excision
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Tension headache
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 23 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    4
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Apr 2019
    The protocol was updated with changes to two inclusion criteria relating to BMI (an increase to the upper limit from 33 to 35 kg/m2) and FEV1 (an increase to the upper limit of the range from 70% to 80%). The upper limit of the inclusion criteria for body mass index and post-bronchodilator FEV1 percentage of the predicted normal value was increased to aid recruitment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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