Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An exploratory, double-blind, randomised, multicenter, psychopharmacological study in adult patients with moderate to severe asthma to compare two pressurised Metered-Dose Inhalers (pMDIs) on patients’ perception of asthma symptoms.

    Summary
    EudraCT number
    		 2021-001449-11
    Trial protocol
    		 IT  
    Global end of trial date
    01 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2024
    First version publication date
    16 Feb 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLI-01535AA0-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04886999
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Chiesi Farmaceutici S.p.A
    Sponsor organisation address
    via Palermo, 26/A, PARMA, Italy, 43122
    Public contact
    Clinical Trial Transparency , Chiesi Farmaceutici S.p.a., clinicaltrials_info@chiesi.com
    Scientific contact
    Clinical Trial Transparency , Chiesi Farmaceutici S.p.a., clinicaltrials_info@chiesi.com
    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
    29 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aimed to assess the perception of symptoms and subject’s preferences comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI, but with different characteristics, in adult subjects whose asthma was already controlled with Foster® 100/6 μg pMDI.
    Protection of trial subjects
    The clinical study was performed in accordance with the principles that have their origin in the Declaration of Helsinki, and with local regulations. The study was carried out in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) notes for guidance on Good Clinical Practice (GCP) (ICH E6 Version 2). Investigators insured a close follow-up of safety signals, and that everything has been done to reduce the burden of study procedures (e.g. no painful procedures, etc.).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Feb 2022
    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
    Italy: 81
    Worldwide total number of subjects
    81
    EEA total number of subjects
    81
    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)
    64
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 81 sbj screened and 78 randomised into 2 study treatment sequences: • 39 CHF1535 Inhaler A (white)-CHF1535 Inhaler B (pink); • 39 CHF1535 Inhaler B (pink)-CHF1535 Inhaler A (white). Of the 78 randomised sbj, 4 discontinued during the baseline period and 74 started the treatment. Data presented in the tables below are referred to those 74 sbj.

    Pre-assignment
    Screening details
    		 After signing the informed consent form, subjects were screened at the investigational site during the screening/randomisation visit (V1). On the same day, and after checking all inclusion and exclusion criteria, eligible subjects were randomised into one of two study treatment sequences.

    Period 1
    Period 1 title
    Treatment Period 1, Treatment Period 2 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The double-blind randomisation ensured that no systematic bias affected the treatment sequence allocation and subject/Investigator perceptions of the study treatments. An Unblinded member of the site was assigned at each site by the Principal Investigator for treatment dispensation, return management, treatment accountability activities; the Unblinded site personnel were distinct from the Blinded Investigator, who performed the other blinded activities such as the collection of the ICF.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence - Inhaler A // Inhaler B
    Arm description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler A/Inhaler B consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 3 subjects discontinued during the baseline period for undergoing adverse events, for consent withdrawal and other reasons.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    CHF1535 100/6 μg pMDI BDP + FF is a drug pressurised inhaler per actuation. It was given twice daily (BID), 2 puffs in the morning preferably before 10.00 am and 2 puffs in the evening preferably before 10.00 pm.

    Arm title
    		 Treatment Sequence - Inhaler B // Inhaler A
    Arm description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler B/Inhaler A consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 1 subject discontinued during the baseline period due to other reason and 2 subjects discontinued due to withdrawal of consent and other reasons during Treatment period 1, while receiving inhaler B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    CHF1535 100/6 μg pMDI BDP + FF is a drug pressurised inhaler per actuation. It was given twice daily (BID), 2 puffs in the morning preferably before 10.00 am and 2 puffs in the evening preferably before 10.00 pm.

    Number of subjects in period 1 [1]
    		Treatment Sequence - Inhaler A // Inhaler B Treatment Sequence - Inhaler B // Inhaler A
    Started
    36
    38
    Completed
    36
    36
    Not completed
    0
    2
         Consent withdrawn by subject
    -
    1
         Other reasons
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 81 subjects enrolled in the trial, 4 screening failures. Of the 78 randomised subjects, 4 discontinued during the baseline period and 74 started the treatment.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment Sequence - Inhaler A // Inhaler B
    Reporting group description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler A/Inhaler B consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 3 subjects discontinued during the baseline period for undergoing adverse events, for consent withdrawal and other reasons.

    Reporting group title
    Treatment Sequence - Inhaler B // Inhaler A
    Reporting group description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler B/Inhaler A consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 1 subject discontinued during the baseline period due to other reason and 2 subjects discontinued due to withdrawal of consent and other reasons during Treatment period 1, while receiving inhaler B.

    Reporting group values
    		 Treatment Sequence - Inhaler A // Inhaler B Treatment Sequence - Inhaler B // Inhaler A Total
    Number of subjects
    		 36 38 74
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 29 28 57
        From 65-84 years
    		 7 10 17
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.0 ( 16.2 ) 51.6 ( 15.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 21 19 40
        Male
    		 15 19 34
    Race
    Units: Subjects
        White
    		 36 38 74
        Asian
    		 0 0 0
        Black or African American
    		 0 0 0
        Other
    		 0 0 0
    Smoking Status
    Units: Subjects
        Non-smoker
    		 26 20 46
        Ex-smoker
    		 9 17 26
        Current smoker
    		 1 1 2
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 26.50 ( 4.36 ) 26.06 ( 4.30 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 75.6 ( 14.7 ) 73.9 ( 14.8 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment Sequence - Inhaler A // Inhaler B
    Reporting group description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler A/Inhaler B consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 3 subjects discontinued during the baseline period for undergoing adverse events, for consent withdrawal and other reasons.

    Reporting group title
    Treatment Sequence - Inhaler B // Inhaler A
    Reporting group description
    		 The 2, 2-week treatment periods in the cross-over design were deemed adequate to evaluate the psychopharmacological aspects and assess the subject’s preferences and perception of symptoms comparing two inhalers containing the same medication/formulation as Foster® 100/6 μg pMDI but with different characteristics. The treatment sequence Inhaler B/Inhaler A consists of: - Baseline treatment with Foster® CHF1535 100/6 μg pMDI, from V1 (Day 1) for a 2-week period; - First treatment period with CHF1535 100/6 μg pMDI with Inhaler B (pink actuator), from V2 (Day 15) to V3 (Day 29); - Second treatment period with CHF1535 100/6 μg pMDI with Inhaler A (white actuator), from V3 (Day 29) to V4 (Day 43). 39 subjects were randomized into this treatment sequence, of whom 36 completed the study. 1 subject discontinued during the baseline period due to other reason and 2 subjects discontinued due to withdrawal of consent and other reasons during Treatment period 1, while receiving inhaler B.

    Subject analysis set title
    Inhaler A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects who took the test product CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF via Inhaler A (white actuator), 2 puffs twice daily (BID). Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Inhaler B
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects who took the reference product CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF via Inhaler B (pink actuator), 2 puffs twice daily (BID). Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - Inhaler A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - Inhaler B
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - No Preference
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - Yes
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - No
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Subject analysis set title
    Answer - I do not know
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Answer given in study-specific subject's questionnaire. Subject analysis set titles will be selected as labels in all the "endpoint values tables".

    Primary: Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #3

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #3
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #3 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the entire 14-days treatment periods. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs. This endpoint is indicated as PRIMARY ENDPOINT to comply with EudraCT register requirements, but it should be considered as an OTHER PRE-SPECIFIED endpoint like the other endpoints listed.
    End point type
    Primary
    End point timeframe
    Question #3 "How would you score your asthma symptoms yesterday?" was to be answered every morning during the 14-days baseline period and over the two 14-days treatment periods.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [1]
    73 [2]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.68 (0.99 to 4.37)
    1.63 (-0.06 to 3.32)
    Notes
    [1] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [2] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 14 days treatment period
    Statistical analysis description
    The analysis was performed on the ITT set. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint and treatment by timepoint interaction as fixed effects. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=145, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.385
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 3.45

    Other pre-specified: Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #4

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #4
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #4 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the entire 14-days treatment periods. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #4 "How burdensome was your asthma yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [3]
    73 [4]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.62 (0.58 to 4.65)
    1.82 (-0.22 to 3.85)
    Notes
    [3] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [4] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 14 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=145, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.582
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 3.68

    Other pre-specified: Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #5

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #5
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #5 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the entire 14-days treatment periods. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #5 "Did your asthma symptoms improve yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [5]
    73 [6]
    Units: score
        arithmetic mean (confidence interval 95%)
    0.25 (-1.27 to 1.76)
    1.54 (0.02 to 3.05)
    Notes
    [5] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [6] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 14 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=145, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.234
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.43
         upper limit
    		 0.85

    Other pre-specified: Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #6

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) perceptions of asthma - over the 14 days of treatment - Question #6
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #6 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the entire 14-days treatment periods. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #6 "Did your asthma symptoms worsen yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [7]
    73 [8]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.53 (0.82 to 4.25)
    1.66 (-0.05 to 3.38)
    Notes
    [7] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [8] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 14 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=145, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.475
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 3.3

    Other pre-specified: Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #3

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #3
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #3 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the first 7 days of treatment. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #3 "How would you score your asthma symptoms yesterday?" was to be answered every morning during the 14-days baseline period and over the first 7 days treatment periods.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    71 [9]
    73 [10]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.91 (1.40 to 4.42)
    1.72 (0.22 to 3.22)
    Notes
    [9] - Number of subjects with available data/Number of subjects in the ITT set: 71/72
    [10] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 7 days treatment period
    Statistical analysis description
    The analysis was performed on the ITT set. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint , period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=144, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.267
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.93
         upper limit
    		 3.31

    Other pre-specified: Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #4

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #4
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #4 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the first 7 days of treatment. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #4 "How burdensome was your asthma yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    71 [11]
    73 [12]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.82 (0.88 to 4.77)
    1.78 (-0.15 to 3.71)
    Notes
    [11] - Number of subjects with available data/Number of subjects in the ITT set: 71/72
    [12] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 7 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=144, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.45
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.7
         upper limit
    		 3.78

    Other pre-specified: Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #5

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #5
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #5 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the first 7 days of treatment. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #5 "Did your asthma symptoms improve yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    71 [13]
    73 [14]
    Units: score
        arithmetic mean (confidence interval 95%)
    0.69 (-1.64 to 3.02)
    1.45 (-0.86 to 3.76)
    Notes
    [13] - Number of subjects with available data/Number of subjects in the ITT set: 71/72
    [14] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 7 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two-sided Confidence Intervals, and p-value. The value N=144, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.648
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    -0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.04
         upper limit
    		 2.53

    Other pre-specified: Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #6

    		 Close Top of page
    End point title
    		 Change from baseline in average VAS score (range 1-100) - over the first 7 days of treatment - Question #6
    End point description
    The analysis was performed on the ITT set. The results of VAS score of asthma symptoms were obtained daily from subjects' answers to Question #6 of study-specific subject's questionnaire. Baseline score is the average of the VAS scores collected during the baseline period and change from baseline is calculated over the first 7 days of treatment. A linear mixed model for repeat measures was used, including subject, period, treatment, timepoint, period by timepoint interaction and treatment by timepoint interaction as fixed effects. Data are presented as adjusted means in each treatment group and their 95% CIs.
    End point type
    Other pre-specified
    End point timeframe
    Question #6 "Did your asthma symptoms worsen yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    71 [15]
    73 [16]
    Units: score
        arithmetic mean (confidence interval 95%)
    2.08 (0.15 to 4.00)
    1.94 (0.02 to 3.85)
    Notes
    [15] - Number of subjects with available data/Number of subjects in the ITT set: 71/72
    [16] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    Statistical analysis title
    		 Change from baseline - 7 days treatment period
    Statistical analysis description
    An unstructured covariance matrix within period was assumed, and the Kenward-Roger adjustment was used for the degrees of freedom. Data are presented as adjusted mean differences with their 95% two sided Confidence Intervals, and p-value. The value N=144, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.919
    Method
    		 Mixed models analysis
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.58
         upper limit
    		 2.86

    Other pre-specified: Psychopharmacological aspects - Question #7

    		 Close Top of page
    End point title
    		 Psychopharmacological aspects - Question #7
    End point description
    The end point evaluates the subject’s questionnaire item (VAS score) related to subjects' expected improving before starting the treatment period. This analysis will be applied on Question #7 of the study-specific subject’s questionnaire. The analysis was performed for the ITT set. Data are presented as arithmetic mean ad standard deviation.
    End point type
    Other pre-specified
    End point timeframe
    Question #7 "Do you expect any improvement in asthma symptoms with this treatment?" was to be answered at specific study visit timepoints (V2 - day 15, V3 - day 29), before starting the treatment period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    50 [17]
    45 [18]
    Units: score
        arithmetic mean (standard deviation)
    64.5 ( 34.3 )
    60.8 ( 36.8 )
    Notes
    [17] - Number of subjects with available data/Number of subjects in the ITT set: 50/72
    [18] - Number of subjects with available data/Number of subjects in the ITT set: 45/74
    No statistical analyses for this end point

    Other pre-specified: Psychopharmacological aspects - Question #8

    		 Close Top of page
    End point title
    		 Psychopharmacological aspects - Question #8
    End point description
    The end point evaluates the subject’s questionnaire item (VAS score) related to subjects' expected worsening before starting the treatment period. This analysis will be applied on Question #8 of the study-specific subject’s questionnaire. The analysis was performed for the ITT set. Data are presented as arithmetic mean ad standard deviation.
    End point type
    Other pre-specified
    End point timeframe
    Question #8 "Do you expect any worsening of your asthma symptoms with this treatment?" was to be answered at specific study visit timepoints (V2 - day 15, V3 - day 29), before starting the treatment period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    50 [19]
    45 [20]
    Units: score
        arithmetic mean (standard deviation)
    8.9 ( 17.0 )
    8.0 ( 16.2 )
    Notes
    [19] - Number of subjects with available data/Number of subjects in the ITT set: 50/72
    [20] - Number of subjects with available data/Number of subjects in the ITT set: 45/74
    No statistical analyses for this end point

    Other pre-specified: Psychopharmacological aspects - Question #9

    		 Close Top of page
    End point title
    		 Psychopharmacological aspects - Question #9
    End point description
    The end point evaluates the subject’s questionnaire item (VAS score) related to subjects' improvement in overall asthma symptoms at the end of the entire treatment period. This analysis will be applied on Question #9 of the study-specific subject’s questionnaire. The analysis was performed for the ITT set. Data are presented as arithmetic mean ad standard deviation.
    End point type
    Other pre-specified
    End point timeframe
    Question #9 "How much do you think this treatment improved your overall asthma symptoms?" was to be answered at specific study visit timepoints (V3 - day 29, V4 - day 43), at the end of the entire treatment period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    55 [21]
    51 [22]
    Units: score
        arithmetic mean (standard deviation)
    41.1 ( 36.5 )
    44.6 ( 35.8 )
    Notes
    [21] - Number of subjects with available data/Number of subjects in the ITT set: 55/72
    [22] - Number of subjects with available data/Number of subjects in the ITT set: 51/74
    No statistical analyses for this end point

    Other pre-specified: Psychopharmacological aspects - Question #10

    		 Close Top of page
    End point title
    		 Psychopharmacological aspects - Question #10
    End point description
    The end point evaluates the subject’s questionnaire item (VAS score) related to subjects' worsening in overall asthma symptoms at the end of the entire treatment period. This analysis will be applied on Question #10 of the study-specific subject’s questionnaire. The analysis was performed for the ITT set. Data are presented as arithmetic mean ad standard deviation.
    End point type
    Other pre-specified
    End point timeframe
    Question #10 "How much do you think this treatment worsened your overall asthma symptoms?" was to be answered at specific study visit timepoints (V3 - day 29, V4 - day 43), at the end of the entire treatment period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    55 [23]
    51 [24]
    Units: score
        arithmetic mean (standard deviation)
    8.0 ( 14.9 )
    11.8 ( 17.2 )
    Notes
    [23] - Number of subjects with available data/Number of subjects in the ITT set: 55/72
    [24] - Number of subjects with available data/Number of subjects in the ITT set: 51/74
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #11

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #11
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #11 "Which inhaler did you visually prefer?" was answered before disclosing that the only difference between the two inhalers was the colour of the actuator.
    End point values
    		 Answer - Inhaler A Answer - Inhaler B Answer - No Preference
    Number of subjects analysed
    14
    17
    27
    Units: %
        arithmetic mean (confidence interval 95%)
    24.1 (13.9 to 37.2)
    29.3 (18.1 to 42.7)
    46.6 (33.3 to 60.1)
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #12

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #12
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #12 "Which inhaler did you prefer to use?" was answered before disclosing that the only difference between the two inhalers was the colour of the actuator.
    End point values
    		 Answer - Inhaler A Answer - Inhaler B Answer - No Preference
    Number of subjects analysed
    20
    16
    22
    Units: %
        arithmetic mean (confidence interval 95%)
    34.5 (22.5 to 48.1)
    27.6 (16.7 to 40.9)
    37.9 (25.5 to 51.6)
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #13

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #13
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #13 "Do you think that changes were made to the inhalers?" was answered before disclosing that the only difference between the two inhalers was the colour of the actuator.
    End point values
    		 Answer - Yes Answer - No Answer - I do not know
    Number of subjects analysed
    27
    17
    14
    Units: %
        arithmetic mean (confidence interval 95%)
    46.6 (33.3 to 60.1)
    29.3 (18.1 to 42.7)
    24.1 (13.9 to 37.2)
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #14

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #14
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #14 "Do you think the changes we made across the inhalers have impacted your asthma symptoms?" was answered before disclosing that the only difference between the 2 inhalers was the colour of the actuator, among the sbj who answered Yes to Q#13.
    End point values
    		 Answer - Yes Answer - No Answer - I do not know
    Number of subjects analysed
    14
    10
    3
    Units: %
        arithmetic mean (confidence interval 95%)
    51.9 (31.9 to 71.3)
    37.0 (19.4 to 57.6)
    11.1 (2.4 to 29.2)
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #15

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #15
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #15 "Based on the information you've received, did it impact your perception of your asthma symptoms?" was answered after disclosure (only at V4).
    End point values
    		 Answer - Yes Answer - No Answer - I do not know
    Number of subjects analysed
    12
    39
    7
    Units: %
        arithmetic mean (confidence interval 95%)
    20.7 (11.2 to 33.4)
    67.2 (53.7 to 79.0)
    12.1 (5.0 to 23.3)
    No statistical analyses for this end point

    Other pre-specified: Subjects' preference and perception of the devices - over the 14 days of treatment - Question #16

    		 Close Top of page
    End point title
    		 Subjects' preference and perception of the devices - over the 14 days of treatment - Question #16
    End point description
    Number and percentage of subjects will be reported on the ITT population by treatment group along with their 95%CI. This analysis will be applied on questions #11, #12, #13, #14, #15 and #16 of the study-specific subject’s questionnaire collected only at V4.
    End point type
    Other pre-specified
    End point timeframe
    Questions #16 "Which of inhaler A or inhaler B had the biggest impact on the perception of your asthma symptoms?" was answered after disclosure (only at V4).
    End point values
    		 Answer - Inhaler A Answer - Inhaler B Answer - No Preference
    Number of subjects analysed
    18
    13
    27
    Units: %
        arithmetic mean (confidence interval 95%)
    31.0 (19.5 to 44.5)
    22.4 (12.5 to 35.3)
    46.6 (33.3 to 60.1)
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in average reliever medication use - over the 14 days of treatment - Question #2

    		 Close Top of page
    End point title
    		 Change from baseline in average reliever medication use - over the 14 days of treatment - Question #2
    End point description
    The analyses will be applied on questions #2 of the study-specific subject’s questionnaire collected daily. Average use (puffs/day) during baseline, average use (puffs/day) during treatment period (over the entire 14 treatment days) and change from baseline will be summarized on the ITT population by treatment group.
    End point type
    Other pre-specified
    End point timeframe
    Question #2 "How many puffs of rescue medication have you taken yesterday?" was to be answered over the entire 14-day treatment period (every morning from the day after V1 to the end of the study at V4).
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [25]
    73 [26]
    Units: puffs/day
        arithmetic mean (standard deviation)
    -0.06 ( 0.69 )
    -0.04 ( 0.74 )
    Notes
    [25] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [26] - Number of subjects with available data/Number of subjects in the ITT set: 73/74
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in AQLQ activity limitation score - after 14 days of treatment

    		 Close Top of page
    End point title
    		 Change from baseline in AQLQ activity limitation score - after 14 days of treatment
    End point description
    The standardised AQLQ scoring system is used to assess quality of life of asthma subjects in this study. It consists of 32 questions divided in 4 domains and has a 7-point scale to assess subject’s condition. Only one response is allowed per question and a subject must answer all the questions.
    End point type
    Other pre-specified
    End point timeframe
    AQLQ(S) scores was performed over the 14-day period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [27]
    72 [28]
    Units: score
        arithmetic mean (standard deviation)
    0.10 ( 0.41 )
    0.04 ( 0.53 )
    Notes
    [27] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [28] - Number of subjects with available data/Number of subjects in the ITT set: 72/74
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in AQLQ symptoms score - after 14 days of treatment

    		 Close Top of page
    End point title
    		 Change from baseline in AQLQ symptoms score - after 14 days of treatment
    End point description
    The standardised AQLQ scoring system is used to assess quality of life of asthma subjects in this study. It consists of 32 questions divided in 4 domains and has a 7-point scale to assess subject’s condition. Only one response is allowed per question and a subject must answer all the questions.
    End point type
    Other pre-specified
    End point timeframe
    AQLQ(S) scores was performed over the 14-day period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [29]
    72 [30]
    Units: score
        arithmetic mean (standard deviation)
    -0.03 ( 0.42 )
    0.00 ( 0.66 )
    Notes
    [29] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [30] - Number of subjects with available data/Number of subjects in the ITT set: 72/74
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in AQLQ emotional function score - after 14 days of treatment

    		 Close Top of page
    End point title
    		 Change from baseline in AQLQ emotional function score - after 14 days of treatment
    End point description
    The standardised AQLQ scoring system is used to assess quality of life of asthma subjects in this study. It consists of 32 questions divided in 4 domains and has a 7-point scale to assess subject’s condition. Only one response is allowed per question and a subject must answer all the questions.
    End point type
    Other pre-specified
    End point timeframe
    AQLQ(S) scores was performed over the 14-day period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [31]
    72 [32]
    Units: score
        arithmetic mean (standard deviation)
    0.06 ( 0.37 )
    0.04 ( 0.71 )
    Notes
    [31] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [32] - Number of subjects with available data/Number of subjects in the ITT set: 72/74
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in AQLQ environmental stimuli score - after 14 days of treatment

    		 Close Top of page
    End point title
    		 Change from baseline in AQLQ environmental stimuli score - after 14 days of treatment
    End point description
    The standardised AQLQ scoring system is used to assess quality of life of asthma subjects in this study. It consists of 32 questions divided in 4 domains and has a 7-point scale to assess subject’s condition. Only one response is allowed per question and a subject must answer all the questions.
    End point type
    Other pre-specified
    End point timeframe
    AQLQ(S) scores was performed over the 14-day period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [33]
    72 [34]
    Units: score
        arithmetic mean (standard deviation)
    0.11 ( 0.70 )
    0.13 ( 0.61 )
    Notes
    [33] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [34] - Number of subjects with available data/Number of subjects in the ITT set: 72/74
    No statistical analyses for this end point

    Other pre-specified: Change from baseline in AQLQ overall score - after 14 days of treatment

    		 Close Top of page
    End point title
    		 Change from baseline in AQLQ overall score - after 14 days of treatment
    End point description
    The standardised AQLQ scoring system is used to assess quality of life of asthma subjects in this study. It consists of 32 questions divided in 4 domains and has a 7-point scale to assess subject’s condition. Only one response is allowed per question and a subject must answer all the questions.
    End point type
    Other pre-specified
    End point timeframe
    AQLQ(S) scores was performed over the 14-day period.
    End point values
    		 Inhaler A Inhaler B
    Number of subjects analysed
    72 [35]
    72 [36]
    Units: score
        arithmetic mean (standard deviation)
    0.05 ( 0.37 )
    0.04 ( 0.53 )
    Notes
    [35] - Number of subjects with available data/Number of subjects in the ITT set: 72/72
    [36] - Number of subjects with available data/Number of subjects in the ITT set: 72/74
    Statistical analysis title
    		 Change from baseline AQLQ(S)
    Statistical analysis description
    Change from baseline in the Standardised Asthma Quality of Life Questionnaire score after 14 days of treatment in each treatment periods was analysed for the ITT set by an analysis of variance (ANOVA) model including treatment, period and subject as fixed effects. Data are presented as adjusted mean differences with their 95% two sided Confidence Intervals, and p-value. The value N=144, shown below, is generated automatically and is due to innate error of the EudraCT database system.
    Comparison groups
    Inhaler A v Inhaler B
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.823
    Method
    		 ANOVA
    Parameter type
    		 Adjusted Mean Difference
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.12

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Safety variables were presented using descriptive statistics. The safety analysis was based on the Safety set using the actual treatment received.
    Adverse event reporting additional description
    All AEs are reported by System Organ Class and Preferred Term and are coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 24.0.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Inhaler A
    Reporting group description
    		 CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF via Inhaler A (white actuator), 2 puffs twice daily (BID).

    Reporting group title
    Inhaler B
    Reporting group description
    		 CHF1535 100/6 μg pMDI fixed dose combination of BDP + FF via Inhaler B (pink actuator), 2 puffs twice daily (BID).

    Serious adverse events
    		 Inhaler A Inhaler B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 74 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Inhaler A Inhaler B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 72 (9.72%)
    6 / 74 (8.11%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Oral discomfort
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 72 (0.00%)
    4 / 74 (5.41%)
         occurrences all number
    0
    4
    Dysphonia
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 72 (0.00%)
    2 / 74 (2.70%)
         occurrences all number
    0
    2
    Rhinitis allergic
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    2 / 72 (2.78%)
    1 / 74 (1.35%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 74 (1.35%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 74 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.

    European Medicines Agency © 1995-Tue May 07 15:07:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA