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    Clinical Trial Results:
    A 26 week, randomized, active-controlled safety study of double-blind formoterol fumarate in free combination with an inhaled corticosteroid versus an inhaled corticosteroid in adolescent and adult patients with persistent asthma

    Summary
    EudraCT number
    		 2012-004854-27
    Trial protocol
    		 GB   LT   SE   LV   HU   EE   FI   DK   ES   SK   PL  
    Global end of trial date
    10 May 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Oct 2017
    First version publication date
    25 Nov 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    update needed for the Pharmaceutical forms and Dosage and administration details for the fluticasone propionate (FP) as this not inhalation powder - hard capsules but inhalation powder

    Trial information

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    Trial identification
    Sponsor protocol code
    CFOR258D2416
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01845025
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate that the addition of formoterol fumarate (FOM) to fluticasone propionate (FP) therapy is non-inferior to FP therapy alone in terms of the risk of composite serious asthma-related events (asthma-related hospitalization, asthma-related intubation and asthma-related death).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 820
    Worldwide total number of subjects
    820
    EEA total number of subjects
    0
    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)
    69
    Adults (18-64 years)
    646
    From 65 to 84 years
    105
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Following the decision to stop further enrollment into the study, 1121 patients had been screened, of whom 825 were randomized. Of the 820 patients randomized and treated and part of Intent To Treat (ITT analysis) 5 patients were randomized but were excluded from the ITT analyses as they did not take study medication.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FOM 12 mcg + FP
    Arm description
    		 Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Formoterol (FOM)
    Investigational medicinal product code
    FOR258
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol (FOM) 12 μg capsules in dry powder inhaler in the morning and evening for 26 weeks

    Investigational medicinal product name
    fluticasone propionate (FP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    fluticasone propionate (FP) 100 mcg, 250 mcg or 500 mcg in dry powder inhaler in the morning and evening for 26 weeks

    Arm title
    		 fluticasone propionate (FP)
    Arm description
    		 fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
    Arm type
    		 Active comparator

    Investigational medicinal product name
    fluticasone propionate (FP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    fluticasone propionate (FP) 100 mcg, 250 mcg or 500 mcg in dry powder inhaler in the morning and evening for 26 weeks

    Investigational medicinal product name
    Placebo to match Formoterol
    Investigational medicinal product code
    FOR258
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo to Match Formoterol (FOM) capsules in dry powder inhaler in the morning and evening for 26 weeks

    Number of subjects in period 1
    		FOM 12 mcg + FP fluticasone propionate (FP)
    Started
    411
    409
    Completed
    326
    332
    Not completed
    85
    77
         Adverse event, serious fatal
    2
    -
         Consent withdrawn by subject
    48
    44
         Adverse event, non-fatal
    6
    3
         Unsatisfactory therapeutic effect
    4
    2
         Protocol deviation
    3
    6
         Administrative problems
    8
    8
         Lost to follow-up
    13
    13
         Missing
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FOM 12 mcg + FP
    Reporting group description
    		 Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation

    Reporting group title
    fluticasone propionate (FP)
    Reporting group description
    		 fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

    Reporting group values
    		 FOM 12 mcg + FP fluticasone propionate (FP) Total
    Number of subjects
    		 411 409 820
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 37 32 69
        Adults (18-64 years)
    		 327 319 646
        From 65-84 years
    		 47 58 105
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.7 ± 16.67 45.6 ± 17.02 -
    Gender, Male/Female
    Units: Subjects
        Male
    		 127 137 264
        Female
    		 284 272 556

    End points

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    End points reporting groups
    Reporting group title
    FOM 12 mcg + FP
    Reporting group description
    		 Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation

    Reporting group title
    fluticasone propionate (FP)
    Reporting group description
    		 fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

    Primary: time to the first occurrence of any composite endpoint including asthma-related hospitalizations, intubations and deaths during the study at 26 weeks

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    End point title
    		 time to the first occurrence of any composite endpoint including asthma-related hospitalizations, intubations and deaths during the study at 26 weeks [1]
    End point description
    The primary safety endpoint was the time to the first occurrence of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    26 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this primary outcome.
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: participants
        Composite event
    3
    3
        Asthma-related death
    0
    0
        Asthma-related intubation
    0
    0
        Asthma-related hospitalization
    3
    3
    No statistical analyses for this end point

    Secondary: Number of asthma exacerbations at 26 weeks

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    End point title
    		 Number of asthma exacerbations at 26 weeks
    End point description
    Number of asthma exacerbations events
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: events
        arithmetic mean (standard deviation)
    1.3 ± 0.62
    1.2 ± 0.51
    No statistical analyses for this end point

    Secondary: Percentage of days of School/Work Missed at 26 weeks

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    End point title
    		 Percentage of days of School/Work Missed at 26 weeks
    End point description
    The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: days
        arithmetic mean (standard deviation)
    0.97 ± 4.558
    0.56 ± 1.641
    No statistical analyses for this end point

    Secondary: Percentage of days with limited ability to perform normal daily activities at 26 weeks

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    End point title
    		 Percentage of days with limited ability to perform normal daily activities at 26 weeks
    End point description
    The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: days
        arithmetic mean (standard deviation)
    4.73 ± 12.774
    4.75 ± 12.705
    No statistical analyses for this end point

    Secondary: Percentage of days with nighttime awakenings at 26 weeks

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    End point title
    		 Percentage of days with nighttime awakenings at 26 weeks
    End point description
    Percentage of days with nighttime awakenings during the treatment period (26 weeks)
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: days
        arithmetic mean (standard deviation)
    4.55 ± 9.577
    4.2 ± 8.956
    No statistical analyses for this end point

    Secondary: Percentage of days with no rescue medication use at 26 weeks

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    End point title
    		 Percentage of days with no rescue medication use at 26 weeks
    End point description
    Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: days
        arithmetic mean (standard deviation)
    76.97 ± 27.255
    73.29 ± 30.64
    No statistical analyses for this end point

    Secondary: Percentage of days with no symptoms at 26 weeks

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    End point title
    		 Percentage of days with no symptoms at 26 weeks
    End point description
    Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: days
        arithmetic mean (standard deviation)
    79.47 ± 25.501
    77.64 ± 28.394
    No statistical analyses for this end point

    Secondary: Change from baseline in Asthma control Questionnaire (ACQ – 6) score at week 26

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    End point title
    		 Change from baseline in Asthma control Questionnaire (ACQ – 6) score at week 26
    End point description
    Change from baseline in Asthma control Questionnaire (ACQ – 6) score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
    End point type
    Secondary
    End point timeframe
    baseline and 26 weeks
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: score on a scale
        arithmetic mean (standard deviation)
    -0.65 ± 1.224
    -0.59 ± 1.094
    No statistical analyses for this end point

    Secondary: Unplanned healthcare utilization at Visit 3, Visit 4 and Visit 5

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    End point title
    		 Unplanned healthcare utilization at Visit 3, Visit 4 and Visit 5
    End point description
    Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).
    End point type
    Secondary
    End point timeframe
    Visit 3, Visit 4 and Visit 5
    End point values
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Number of subjects analysed
    411
    409
    Units: unplanned visits
        Telephone contact with study MD: V3
    19
    18
        Telephone contact with other MD or HCP: V3
    5
    9
        unplanned visit to study MD;include home:V3
    7
    13
        unplanned visit to other MD or HCP incl.home:V3
    5
    9
        Emergency or hospital visit (< 24 hours):V3
    3
    4
        Hospital admission or Emergency visit (>24hrs):V3
    1
    1
        Telephone contact with study MD: V4
    25
    17
        Telephone contact with other MD or HCP: V4
    5
    7
        unplanned visit to study MD;include home:V4
    10
    15
        unplanned visit to other MD or HCP incl.home:V4
    15
    16
        Emergency or hospital visit (< 24 hours):V4
    3
    4
        Hospital admission or Emergency visit (>24hrs):V4
    0
    2
        Telephone contact with study MD: V5
    14
    9
        Telephone contact with other MD or HCP: V5
    8
    2
        unplanned visit to study MD;include home:V5
    6
    9
        unplanned visit to other MD or HCP incl.home:V5
    10
    7
        Emergency or hospital visit (< 24 hours):V5
    4
    6
        Hospital admission or Emergency visit (>24hrs):V5
    2
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    FOM 12 mcg + FP
    Reporting group description
    		 Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation

    Reporting group title
    fluticasone propionate (FP)
    Reporting group description
    		 fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation

    Serious adverse events
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 411 (2.43%)
    9 / 409 (2.20%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer metastatic
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 411 (0.49%)
    2 / 409 (0.49%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    2 / 411 (0.49%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 411 (0.24%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 411 (0.00%)
    1 / 409 (0.24%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 411 (0.24%)
    0 / 409 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 FOM 12 mcg + FP fluticasone propionate (FP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 411 (1.22%)
    9 / 409 (2.20%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    5 / 411 (1.22%)
    9 / 409 (2.20%)
         occurrences all number
    7
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Apr 2015
    Amendment 1: Clarified inclusion of women of child-bearing potential. Clarified exclusion of patients with history of malignancy and cardiovascular conditions. Clarified that contacting the medical monitor was not mandatory before unblinding. Added assessment of pharmacogenetic sampling and the timing of sampling with respect to the visit schedule, details of the sampling technique and the analysis plan. Clarified the sample size calculation and non-inferiority margin.

    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.
    Due to the action to withdraw the Foradil Aerolizer NDA in US; study was discontinued. This was a commercial reason and not due to any change in benefit-risk.
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    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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