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    Clinical Trial Results:
    A SINGLE CENTRE DOUBLE-BLIND, RANDOMISED 3 PERIOD CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF BECLOMETHASONE DIPROPIONATE HFA pMDI 100 AND 200 µg B.I.D. USING AEROCHAMBER PLUS™ SPACING DEVICE AND BECLOMETHASONE DIPROPIONATE HFA pMDI 200 µg B.I.D. USING THE VOLUMATIC™ SPACING DEVICE IN CHILDREN WITH MILD ASTHMA DURING A 2–WEEK TREATMENT PERIOD

    Summary
    EudraCT number
    		 2007-003412-59
    Trial protocol
    		 DK  
    Global end of trial date
    27 Dec 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Nov 2017
    First version publication date
    10 Nov 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CCD-0704-PR-0024
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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., +39 0521 2791, ClinicalTrials_info@chiesi.com
    Scientific contact
    Clinical Trial Transparency, Chiesi Farmaceutici S.p.A., +39 0521 2791, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Dec 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare lower leg growth rate (LLGR), measured by knemometry, during a 2-week treatment period with BDP HFA pMDI 200 µg b.i.d. using AeroChamber Plus™ spacing device versus BDP HFA pMDI 200 µg b.i.d. using Volumatic™ spacing device.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines and local law requirements. Other than routine care, no specific measures for protection of trial subjects were implemented.
    Background therapy
    		 -
    Evidence for comparator
    		 During the one-week training period the patients have familiarized with the actuators, the AeroChamber(TM) spacer and Volumatic (TM) spacer devices and the procedures to take place during the study. Patients were be off inhalation of corticosteroid treatment in the training period.
    Actual start date of recruitment
    17 Sep 2007
    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
    Denmark: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    19
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of thirty (30) outpatients were enrolled.

    Pre-assignment
    Screening details
    		 Children (males and females) 6-14 years old (inclusive), with a clinical diagnosis of mild asthma during at least two months prior to screening visit were selected.

    Pre-assignment period milestones
    Number of subjects started
    		 26
    Intermediate milestone: Number of subjects
    Run In- Placebo HFA pMDI: 26
    Number of subjects completed
    		 26

    Period 1
    Period 1 title
    Overall trial by sequence (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
    		 Sequence A (treatments A-B-C)
    Arm description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment A: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks. Treatment B: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks. Treatment C: BDP HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment A: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment B: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment C: placebo HFA pMDI via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Arm title
    		 Sequence B (treatments A-C-B)
    Arm description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment A: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks. Treatment C: BDP HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks. Treatment B: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment A: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment C: placebo HFA pMDI via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment B: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Arm title
    		 Sequence C (treatments B-A-C)
    Arm description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment B: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks. Treatment A: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks. Treatment C: BDP HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment B: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment A: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment C: placebo HFA pMDI via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Arm title
    		 Sequence D (treatments B-C-A)
    Arm description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    Beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment B: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks. Treatment C: BDP HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks. Treatment A: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment B: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment C: placebo HFA pMDI via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment A: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Arm title
    		 Sequence E (treatments C-A-B)
    Arm description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    Beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment C: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks. Treatment A: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks. Treatment B: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment C: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment A: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment B: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Arm title
    		 Sequence F (treatments C-B-A)
    Arm description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BDP HFA pMDI
    Investigational medicinal product code
    Other name
    beclomethasone dipropionate
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment C: BDP hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Volumatic™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for 2 weeks. Treatment B: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (50 μg / actuation) for two weeks. Treatment A: BDP HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d. (100 μg / actuation) for two weeks.

    Investigational medicinal product name
    placebo HFA pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment C: placebo hydrofluoroalcane (HFA) by pressurized metered-dose inhaler (pMDI) via Aerochamber Plus™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment B: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks. Treatment A: placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d. for 2 weeks.

    Number of subjects in period 1
    		Sequence A (treatments A-B-C) Sequence B (treatments A-C-B) Sequence C (treatments B-A-C) Sequence D (treatments B-C-A) Sequence E (treatments C-A-B) Sequence F (treatments C-B-A)
    Started
    3
    4
    5
    4
    5
    5
    Completed
    3
    4
    5
    4
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial by sequence
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial by sequence Total
    Number of subjects
    		 26 26
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.8 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Treatment A - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Treatment B - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Treatment C - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Run-in Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis sets values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects
    26
    26
    26
    26
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    9.8 ± 10
    9.8 ± 10
    9.8 ± 10
    9.8 ± 10
    Gender categorical
    Units: Subjects
        Female
    11
    11
    11
    11
        Male
    15
    15
    15
    15

    End points

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    End points reporting groups
    Reporting group title
    Sequence A (treatments A-B-C)
    Reporting group description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Reporting group title
    Sequence B (treatments A-C-B)
    Reporting group description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Reporting group title
    Sequence C (treatments B-A-C)
    Reporting group description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Reporting group title
    Sequence D (treatments B-C-A)
    Reporting group description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Reporting group title
    Sequence E (treatments C-A-B)
    Reporting group description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Reporting group title
    Sequence F (treatments C-B-A)
    Reporting group description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. A run-in period with Placebo HFA pMDI (2 inhalations bid, via AeroChamber Plus1M spacer and via Volumatic(TM) spacer in the morning and in the evening for 2 weeks) preceded the first active section. The second and the third active sections were preceded by a 2-week wash-out period.

    Subject analysis set title
    Treatment A - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Treatment B - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Treatment C - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Subject analysis set title
    Run-in Placebo - ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intention-To-Treat analysis set (ITT), consisted of data from all patients, who were randomised and exposed to at least one dose of study product in the treatment period.

    Primary: Lower leg growth rate measured by knemometry

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    End point title
    		 Lower leg growth rate measured by knemometry
    End point description
    Lower leg growth rate (LLGR) measured by knemometry during a 2-week treatment period with BDP HFA pMDI 200 μg b.i.d. via AeroChamber Plus™ spacer versus BDP HFA pMDI 200 μg b.i.d. via Volumatic™ spacer.
    End point type
    Primary
    End point timeframe
    At Visit 2 during training period and at Visit 3 (randomisation), Visit 4 (week 2), Visit 5 (week 4), Visit 6 (week 6), Visit 7 (week 8) and Visit 8 (end of treatment) during the active period.
    End point values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects analysed
    26
    26
    26
    26
    Units: mm/wk
        arithmetic mean (standard deviation)
    0.23 ± 0.325
    0.3 ± 0.303
    0.26 ± 0.288
    0.39 ± 0.24
    Statistical analysis title
    		 Treatment A vs Treatment C
    Comparison groups
    Treatment A - ITT population v Treatment C - ITT population
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.13
    Notes
    [1] - The LLGR was analyzed using ANOVA with treatments and periods as fixed effects, patients as a random effect and the baseline LLGR as a covariate. The difference 100 μg AeroChamber – 100 μg Volumatic for adjusted treatment means was presented with a two-sided 95% confidence interval. If the left endpoint of this interval is greater than or equal to -0.2 mm/week non-inferiority is declared.

    Secondary: Pre-dose morning PEF

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    End point title
    		 Pre-dose morning PEF
    End point description
    The parameter was measured at home daily during each study period. At the training visit, a Patient Diary Card was handed out to the patient. The patient would follow instructions for measuring PEF (morning and evening) with a Mini-Wright Peak Flow Meter and scoring asthma symptoms.
    End point type
    Secondary
    End point timeframe
    At screening, at Visit 2 during training period and at Visit 3 (randomisation), Visit 4 (week 2), Visit 5 (week 4), Visit 6 (week 6), Visit 7 (week 8) and Visit 8 (end of treatment) during the active period.
    End point values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects analysed
    26
    26
    26
    26
    Units: L/min)
        arithmetic mean (standard deviation)
    253 ± 58.2
    257.3 ± 62.8
    260.7 ± 59.1
    249.1 ± 56.2
    No statistical analyses for this end point

    Secondary: Pre-dose evening PEF

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    End point title
    		 Pre-dose evening PEF
    End point description
    The parameter was measured at home daily during each study period. At the training visit, a Patient Diary Card was handed out to the patient. The patient would follow instructions for measuring PEF (morning and evening) with a Mini-Wright Peak Flow Meter and scoring asthma symptoms.
    End point type
    Secondary
    End point timeframe
    At screening, at Visit 2 during training period and at Visit 3 (randomisation), Visit 4 (week 2), Visit 5 (week 4), Visit 6 (week 6), Visit 7 (week 8) and Visit 8 (end of treatment) during the active period.
    End point values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects analysed
    26
    26
    26
    26
    Units: L/min
        arithmetic mean (standard deviation)
    254.8 ± 58
    257.3 ± 62.9
    263.4 ± 62.1
    248.8 ± 55.5
    No statistical analyses for this end point

    Secondary: Asthma symptom score (Total)

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    End point title
    		 Asthma symptom score (Total)
    End point description
    At the training visit, a Patient Diary Card was handed out to the patient. The patient would follow instructions for measuring PEF (morning and evening) with a Mini-Wright Peak Flow Meter and scoring asthma symptoms.
    End point type
    Secondary
    End point timeframe
    At Visit 2 during training period and at Visit 3 (randomisation), Visit 4 (week 2), Visit 5 (week 4), Visit 6 (week 6), Visit 7 (week 8) till the end of treatment during the active period.
    End point values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects analysed
    26
    26
    26
    26
    Units: score
        arithmetic mean (standard deviation)
    0.23 ± 0.63
    0.21 ± 0.62
    0.21 ± 0.6
    0.29 ± 0.64
    No statistical analyses for this end point

    Secondary: Daily use of rescue medication

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    End point title
    		 Daily use of rescue medication
    End point description
    Inhaled terbutaline was administered as rescue medication. A minimum period of 4 hours should elapse between the use of rescue terbutaline and the spirometric measurements
    End point type
    Secondary
    End point timeframe
    Throughout the study from training period to End of Treatment.
    End point values
    		 Treatment A - ITT population Treatment B - ITT population Treatment C - ITT population Run-in Placebo - ITT population
    Number of subjects analysed
    26
    25
    24
    24
    Units: number of doses
        arithmetic mean (standard deviation)
    0.14 ± 0.42
    0.03 ± 0.09
    0.05 ± 0.14
    0.14 ± 0.29
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At each visit in both the training period (Visits 1 and 2) and the active period (Visits 3 throug Visit 8).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Sequence A (treatments A-B-C)
    Reporting group description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Reporting group title
    Sequence B (treatments A-C-B)
    Reporting group description
    		 - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Reporting group title
    Sequence C (treatments B-A-C)
    Reporting group description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Reporting group title
    Sequence D (treatments B-C-A)
    Reporting group description
    		 - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Reporting group title
    Sequence E (treatments C-A-B)
    Reporting group description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Reporting group title
    Sequence F (treatments C-B-A)
    Reporting group description
    		 - Treatment C: BDP HFA pMDI (100 μg / actuation) via Volumatic™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via AeroChamber Plus™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment B: BDP HFA pMDI (50 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. - Treatment A: BDP HFA pMDI (100 μg / actuation) via AeroChamber Plus™ spacer, 2 inhalations b.i.d., + placebo HFA pMDI via Volumatic™ spacer, 2 inhalations b.i.d., for 2 weeks. Each active section was preceded by a 2-week wash-out period.

    Serious adverse events
    		 Sequence A (treatments A-B-C) Sequence B (treatments A-C-B) Sequence C (treatments B-A-C) Sequence D (treatments B-C-A) Sequence E (treatments C-A-B) Sequence F (treatments C-B-A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.03%
    Non-serious adverse events
    		 Sequence A (treatments A-B-C) Sequence B (treatments A-C-B) Sequence C (treatments B-A-C) Sequence D (treatments B-C-A) Sequence E (treatments C-A-B) Sequence F (treatments C-B-A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    3 / 4 (75.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Middle ear effusion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

    More information

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    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.
    There are no limitations nor caveats applicable to this summary of results.
    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
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