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    Clinical Trial Results:
    A randomized, placebo-controlled, dose-ranging, multi-centre trial of QAW039 (1-450 mg p.o.), to investigate the effect on FEV1 and ACQ in patients with moderate-to-severe, persistent, allergic asthma, inadequately controlled with ICS therapy

    Summary
    EudraCT number
    		 2011-001062-18
    Trial protocol
    		 GR   GB   AT   HU   PL   NL   IT   BG  
    Global end of trial date
    12 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Aug 2018
    First version publication date
    05 Aug 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CQAW039A2206
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01437735
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002 , Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Nov 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate a clinically significant improvement in morning FEV1 in moderate to severe allergic asthmatics inadequately controlled by ICS therapy treated with QAW039 for 12 weeks compared to placebo.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. At Visit 1 all patients were provided with a salbutamol/albuterol propellant –HFA 134a) inhaler which they were instructed to use throughout the study as rescue medication. The rescue medication usage was collected daily in the diary between study visits.
    Background therapy
    		 All patients were treated with 200µg budesonide bid throughout the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 2011
    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
    Argentina: 47
    Country: Number of subjects enrolled
    Colombia: 26
    Country: Number of subjects enrolled
    Guatemala: 37
    Country: Number of subjects enrolled
    India: 104
    Country: Number of subjects enrolled
    Japan: 124
    Country: Number of subjects enrolled
    Mexico: 52
    Country: Number of subjects enrolled
    Peru: 53
    Country: Number of subjects enrolled
    Romania: 62
    Country: Number of subjects enrolled
    Russian Federation: 60
    Country: Number of subjects enrolled
    South Africa: 67
    Country: Number of subjects enrolled
    Turkey: 13
    Country: Number of subjects enrolled
    United States: 211
    Country: Number of subjects enrolled
    Netherlands: 9
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Austria: 26
    Country: Number of subjects enrolled
    Bulgaria: 44
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Hungary: 79
    Country: Number of subjects enrolled
    Italy: 3
    Worldwide total number of subjects
    1058
    EEA total number of subjects
    263
    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)
    1044
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After obtaining informed consent at Visit 1, the patients were advised on wash out requirements for prohibited medications prior to screening at Visit 2 or 3 .

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 3 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 10 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 30 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 50 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 75 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 150 mg bid QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 300 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 450 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 2 mg bid QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 25 mg bid QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 75 mg bid QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 150 mg qd QAW039
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 10 mg qd montelukas
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Arm title
    		 Placebo
    Arm description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    QAW039/placebo study medication to be taken in the morning between 08:00 and 11:00 am. At Visits 4 to 8; the study medication was administered in the clinic between 08:00 and 11:00 am. Patients were instructed to withhold the use rescue medication for at least 6 hours prior to all clinic visits, unless the use was absolutely necessary. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Number of subjects in period 1
    		1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 10 mg qd montelukas Placebo
    Started
    52
    54
    48
    55
    51
    58
    56
    57
    134
    52
    60
    52
    53
    139
    137
    Completed
    41
    44
    41
    46
    43
    51
    50
    51
    107
    45
    54
    37
    43
    113
    111
    Not completed
    11
    10
    7
    9
    8
    7
    6
    6
    27
    7
    6
    15
    10
    26
    26
         Abnormal laboratory value(s)
    2
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    1
    1
    1
         Consent withdrawn by subject
    -
    3
    3
    -
    -
    -
    -
    -
    6
    1
    1
    1
    2
    10
    2
         Patient's inability to use the device
    -
    1
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    4
    2
    2
    7
    4
    3
    4
    2
    14
    4
    1
    7
    4
    5
    16
         Unsatisfactory therapeutic effect
    2
    -
    -
    -
    -
    -
    -
    1
    1
    -
    -
    1
    1
    1
    1
         Administrative problems
    -
    -
    1
    -
    -
    1
    -
    1
    -
    -
    2
    -
    1
    3
    -
         patients randomized in error/no data available
    1
    2
    -
    1
    2
    -
    -
    -
    1
    1
    1
    1
    -
    2
    1
         Lost to follow-up
    -
    -
    -
    1
    -
    -
    2
    1
    2
    -
    1
    1
    1
    1
    2
         Abnormal test procedure result(s)
    -
    1
    -
    -
    1
    1
    -
    1
    1
    -
    -
    -
    -
    1
    2
         Protocol deviation
    2
    1
    1
    -
    -
    2
    -
    -
    1
    1
    -
    4
    -
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    1 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    3 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    10 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    30 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    50 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    75 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    150 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    300 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    450 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    2 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    25 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    75 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    150 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    10 mg qd montelukas
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    Placebo
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group values
    		 1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 10 mg qd montelukas Placebo Total
    Number of subjects
    		 52 54 48 55 51 58 56 57 134 52 60 52 53 139 137 1058
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 51 53 47 53 51 57 55 57 132 52 60 52 53 136 135 1044
        From 65-84 years
    		 1 1 1 2 0 1 1 0 2 0 0 0 0 3 2 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.4 ( 11.69 ) 44.2 ( 13.22 ) 43.1 ( 12.19 ) 44.7 ( 14.15 ) 46.9 ( 10.11 ) 46.4 ( 12.45 ) 45.6 ( 13.52 ) 40.8 ( 12.07 ) 45.8 ( 12.51 ) 48.1 ( 11.1 ) 44.7 ( 11.54 ) 45.4 ( 10.44 ) 42.4 ( 12.6 ) 44.5 ( 11.25 ) 44.6 ( 12.46 ) -
    Gender categorical
    Units: Subjects
        Female
    		 35 32 23 29 25 30 36 33 74 32 39 35 29 81 79 612
        Male
    		 17 22 25 26 26 28 20 24 60 20 21 17 24 58 58 446

    End points

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    End points reporting groups
    Reporting group title
    1 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    3 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    10 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    30 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    50 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    75 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    150 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    300 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    450 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    2 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    25 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    75 mg bid QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    150 mg qd QAW039
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    10 mg qd montelukas
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Reporting group title
    Placebo
    Reporting group description
    		 The study medication was administered in the clinic in the morning. On non-visit days, patients were instructed to take all three capsules in the morning between 08:00 and 11:00 from their QAW039/placebo medication kits. On all days, patients were instructed to take their 3 evening capsules of QAW039/placebo and their capsule of montelukast/placebo approximately 12 hours after their AM dose ± 30 minutes.

    Subject analysis set title
    QAW039 75 mg qd v/s QAW039 25 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 150 mg qd v/s QAW039 75 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 50 mg qd v/s QAW039 25 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 10 mg qd v/s QAW039 2 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 150 mg qd v/s QAW039 150 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 450 mg qd v/s QAW039 150 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 300 mg qd v/s QAW039 150 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 75 mg qd v/s QAW039 75 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Subject analysis set title
    QAW039 300 mg qd v/s QAW039 75 mg bid
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Comparison between regimens of selected doses

    Primary: Dose-response results of trough Forced Expiratory Volume in 1 second (FEV1) after 12 weeks of treatment

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    End point title
    		 Dose-response results of trough Forced Expiratory Volume in 1 second (FEV1) after 12 weeks of treatment [1] [2]
    End point description
    Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been reported for this primary end point.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reporting statistics for the Placebo arm since it is not the arm that is being evaluated for this endpoint.
    End point values
    		 1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 10 mg qd montelukas
    Number of subjects analysed
    52
    54
    48
    55
    51
    58
    56
    57
    134
    52
    60
    52
    53
    139
    Units: Liters
    number (confidence interval 95%)
        Absolute increase over Placebo
    0.0054 (0 to 0.1473)
    0.0189 (0 to 0.161)
    0.0476 (0 to 0.1647)
    0.0881 (0 to 0.1685)
    0.0954 (0 to 0.1697)
    0.1019 (0.0009 to 0.1708)
    0.1122 (0.0036 to 0.1753)
    0.1097 (0.0065 to 0.1739)
    0.1107 (0.0104 to 0.1746)
    0.0027 (0 to 10.1113)
    0.1043 (0.0004 to 0.1668)
    0.1104 (0.0016 to 0.1713)
    0.1078 (0.0029 to 0.1725)
    0.1324 (0.0427 to 0.2252)
        % of projected effect of maximum QAW039 dose
    4.9 (0 to 99.6)
    16.8 (0 to 100)
    42.4 (0 to 100)
    95.5 (0 to 100)
    98.2 (0.8 to 100)
    99.1 (16.7 to 100)
    100.0 (67.3 to 221.9)
    100 (66.7 to 100)
    0 (0 to 0)
    5.8 (0 to 82.6)
    100 (11.4 to 105.2)
    100 (40.4 to 170)
    99.9 (33.3 to 100.0)
    119.3 (32.1 to 227.1)
    No statistical analyses for this end point

    Secondary: Change in the Asthma Control Questionnaire (ACQ7) score from baseline to week 12

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    End point title
    		 Change in the Asthma Control Questionnaire (ACQ7) score from baseline to week 12
    End point description
    The Asthma Control Questionnaire (ACQ) is a validated questionnaire consisting of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 assessing the patients Forced Expiratory Volume in 1 second (FEV1) result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.
    End point type
    Secondary
    End point timeframe
    Baseline and week 12
    End point values
    		 1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 10 mg qd montelukas Placebo
    Number of subjects analysed
    52
    54
    48
    55
    51
    58
    56
    57
    134
    52
    60
    52
    53
    139
    137
    Units: Units on a scale
    least squares mean (confidence interval 95%)
        Change from baseline
    -0.758 (-0.954 to -0.561)
    -0.636 (-0.836 to -0.436)
    -0.603 (-0.806 to -0.399)
    -0.612 (-0.805 to -0.42)
    -0.529 (-0.722 to -0.337)
    -0.617 (-0.805 to -0.428)
    -0.548 (-0.731 to -0.365)
    -0.721 (-0.908 to -0.533)
    -0.666 (-0.795 to -0.537)
    -0.681 (-0.872 to -0.49)
    -0.563 (-0.745 to -0.381)
    -0.737 (-0.95 to -0.523)
    -0.653 (-0.847 to -0.46)
    -0.68 (-0.806 to -0.554)
    -0.631 (-0.761 to -0.502)
        Difference to Placebo
    -0.127 (-0.351 to 0.098)
    -0.005 (-0.23 to 0.22)
    0.029 (-0.202 to 0.259)
    0.019 (-0.197 to 0.235)
    0.102 (-0.119 to 0.323)
    0.015 (-0.2 to 0.299)
    0.083 (-0.126 to 0.293)
    -0.089 (-0.303 to 0.124)
    -0.035 (-0.2 to 0.131)
    -0.05 (-0.27 to 0.17)
    0.068 (-0.141 to 0.277)
    -0.105 (-0.345 to 0.134)
    -0.022 (-0.243 to 0.199)
    -0.049 (-0.213 to 0.115)
    0 (0 to 0)
        Difference to Montelukast
    -0.078 (-0.3 to 0.144)
    0.044 (-0.179 to 0.267)
    0.077 (-0.152 to 0.306)
    0.068 (-0.149 to 0.284)
    0.151 (-0.068 to 0.37)
    0.063 (-0.151 to 0.277)
    0.132 (-0.077 to 0.34)
    -0.041 (-0.253 to 0.171)
    0.014 (-0.15 to 0.178)
    -0.001 (-0.219 to 0.217)
    0.117 (-0.091 to 0.324)
    -0.057 (-0.294 to 0.181)
    0.026 (-0.194 to 0.246)
    0 (0 to 0)
    0.049 (-0.115 to 0.213)
    No statistical analyses for this end point

    Secondary: Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment

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    End point title
    		 Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment
    End point description
    Forced Expiratory Volume in 1 second (FEV1) (measured in liters), and the measurement is taken 24 hours after the morning dose on the previous day.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 QAW039 150 mg qd v/s QAW039 75 mg bid QAW039 75 mg qd v/s QAW039 25 mg bid QAW039 50 mg qd v/s QAW039 25 mg bid QAW039 10 mg qd v/s QAW039 2 mg bid QAW039 150 mg qd v/s QAW039 150 mg bid QAW039 450 mg qd v/s QAW039 150 mg bid QAW039 300 mg qd v/s QAW039 150 mg bid QAW039 75 mg qd v/s QAW039 75 mg bid QAW039 300 mg qd v/s QAW039 75 mg bid
    Number of subjects analysed
    105
    118
    111
    100
    109
    190
    113
    110
    109
    Units: Liter
        least squares mean (confidence interval 95%)
    0 (-0.0556 to 0.017)
    0 (-0.0697 to 0.0423)
    0 (-0.107 to 0.0313)
    0.0111 (-0.0303 to 0.1515)
    0 (-0.0755 to 0.0114)
    0 (-0.048 to 0.02)
    0 (-0.0576 to 0.016)
    0 (-0.0889 to 0.0125)
    0 (-0.0397 to 0.0221)
    No statistical analyses for this end point

    Secondary: Comparison of efficacy of QAW039 with that of montelukast as an add-on therapy to Inhaled Corticosteroids (ICS)

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    End point title
    		 Comparison of efficacy of QAW039 with that of montelukast as an add-on therapy to Inhaled Corticosteroids (ICS) [3]
    End point description
    Forced Expiratory Volume in 1 second (FEV1) measurement taken 24 hours after the morning dose on the previous day. The Asthma Control Questionnaire (ACQ)consisting of 7 items: 5 on system assessment, 1 on rescue bronchodilator use and 1 assessing the patients for FEV1 result against the predicted result for a person of similar age and stature. Each item is graded on a scale of 0-6, and a mean score of 1.5 or greater is considered to demonstrate inadequate asthma control in this trial. The minimal important difference that is considered clinically important is a change of 0.5 in the mean score.
    End point type
    Secondary
    End point timeframe
    Week 12
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The end point is not reporting statistics for the Montelukast arm since it is not the arm that is being evaluated for this endpoint.
    End point values
    		 1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 Placebo
    Number of subjects analysed
    52
    54
    48
    55
    51
    58
    56
    57
    134
    52
    60
    52
    53
    137
    Units: Liter
        least squares mean (confidence interval 95%)
    -0.058 (-0.18 to 0.063)
    -0.046 (-0.167 to 0.074)
    -0.132 (-0.258 to -0.005)
    -0.042 (-0.161 to 0.076)
    -0.082 (-0.204 to 0.041)
    -0.022 (-0.14 to 0.096)
    -0.07 (-0.187 to 0.047)
    -0.014 (-0.13 to 0.103)
    -0.056 (-0.145 to 0.032)
    -0.147 (-0.267 to -0.027)
    0.012 (-0.103 to 0.126)
    0.046 (-0.081 to 0.173)
    0.031 (-0.089 to 0.15)
    -0.134 (-0.222 to -0.045)
    No statistical analyses for this end point

    Secondary: To assess the effect of QAW039 on asthma symptoms as measured by the Juniper asthma control diary (JACD).

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    End point title
    		 To assess the effect of QAW039 on asthma symptoms as measured by the Juniper asthma control diary (JACD).
    End point description
    The asthma control diary mimics the Asthma Control Questionnaire (ACQ), but is recorded daily by the patient, rather than at each visit. All patients were instructed to complete the patient diary twice daily, once in the morning and once approximately 12 h later in the evening from screening through the study. As for the ACQ, the ACD consists of 7 questions. The Modified Full analysis set was used. The modified full analysis set (mFAS) included all randomized patients who received at least one dose of study drug and who had valid baseline and post baseline spirometry data.
    End point type
    Secondary
    End point timeframe
    Baseline and week 12
    End point values
    		 1 mg qd QAW039 3 mg qd QAW039 10 mg qd QAW039 30 mg qd QAW039 50 mg qd QAW039 75 mg qd QAW039 150 mg bid QAW039 300 mg qd QAW039 450 mg qd QAW039 2 mg bid QAW039 25 mg bid QAW039 75 mg bid QAW039 150 mg qd QAW039 10 mg qd montelukas Placebo
    Number of subjects analysed
    37
    34
    30
    39
    33
    39
    55
    37
    94
    38
    41
    33
    36
    100
    98
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Baseline
    1.69 ( 0.546 )
    1.72 ( 0.583 )
    1.72 ( 0.606 )
    1.61 ( 0.58 )
    1.74 ( 0.579 )
    1.86 ( 0.835 )
    1.65 ( 0.743 )
    1.86 ( 0.766 )
    1.71 ( 0.721 )
    1.67 ( 0.605 )
    1.88 ( 0.784 )
    1.59 ( 0.662 )
    1.77 ( 0.69 )
    1.7 ( 0.731 )
    1.79 ( 0.703 )
        Post Baseline
    1.44 ( 0.55 )
    1.59 ( 0.718 )
    1.43 ( 0.635 )
    1.51 ( 0.518 )
    1.65 ( 0.651 )
    1.71 ( 1.007 )
    1.51 ( 0.713 )
    1.64 ( 0.662 )
    1.49 ( 0.654 )
    1.49 ( 0.542 )
    1.68 ( 0.917 )
    1.45 ( 0.732 )
    1.55 ( 0.758 )
    1.47 ( 0.771 )
    1.64 ( 0.723 )
        Change from Baseline
    -0.25 ( 0.446 )
    -0.12 ( 0.407 )
    -0.29 ( 0.526 )
    -0.09 ( 0.323 )
    -0.09 ( 0.44 )
    -0.15 ( 0.589 )
    -0.14 ( 0.431 )
    -0.22 ( 0.512 )
    -0.22 ( 0.47 )
    -0.18 ( 0.37 )
    -0.21 ( 0.646 )
    -0.14 ( 0.404 )
    -0.21 ( 0.445 )
    -0.23 ( 0.46 )
    -0.15 ( 0.527 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    QAW039 450mg QD
    Reporting group description
    		 QAW039 450mg QD

    Reporting group title
    Montelukast 10mg QD
    Reporting group description
    		 Montelukast 10mg QD

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    QAW039 low dose
    Reporting group description
    		 QAW039 low dose

    Reporting group title
    QAW039 mid dose
    Reporting group description
    		 QAW039 mid dose

    Reporting group title
    QAW039 top dose
    Reporting group description
    		 QAW039 top dose

    Serious adverse events
    		 QAW039 450mg QD Montelukast 10mg QD Placebo QAW039 low dose QAW039 mid dose QAW039 top dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 133 (2.26%)
    1 / 133 (0.75%)
    2 / 136 (1.47%)
    4 / 201 (1.99%)
    4 / 219 (1.83%)
    2 / 212 (0.94%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostatic adenoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    1 / 219 (0.46%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    1 / 219 (0.46%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    1 / 201 (0.50%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 133 (0.75%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    1 / 136 (0.74%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    1 / 201 (0.50%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma exacerbation
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 133 (0.00%)
    1 / 136 (0.74%)
    1 / 201 (0.50%)
    1 / 219 (0.46%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    1 / 201 (0.50%)
    0 / 219 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    0 / 219 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 133 (0.00%)
    0 / 136 (0.00%)
    0 / 201 (0.00%)
    1 / 219 (0.46%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 QAW039 450mg QD Montelukast 10mg QD Placebo QAW039 low dose QAW039 mid dose QAW039 top dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 133 (16.54%)
    27 / 133 (20.30%)
    28 / 136 (20.59%)
    30 / 201 (14.93%)
    40 / 219 (18.26%)
    38 / 212 (17.92%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 133 (7.52%)
    8 / 133 (6.02%)
    8 / 136 (5.88%)
    10 / 201 (4.98%)
    10 / 219 (4.57%)
    9 / 212 (4.25%)
         occurrences all number
    12
    8
    10
    11
    11
    11
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    6 / 133 (4.51%)
    4 / 133 (3.01%)
    11 / 136 (8.09%)
    4 / 201 (1.99%)
    5 / 219 (2.28%)
    10 / 212 (4.72%)
         occurrences all number
    6
    4
    11
    4
    6
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 133 (3.76%)
    10 / 133 (7.52%)
    7 / 136 (5.15%)
    11 / 201 (5.47%)
    21 / 219 (9.59%)
    15 / 212 (7.08%)
         occurrences all number
    6
    13
    9
    11
    25
    19
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 133 (2.26%)
    11 / 133 (8.27%)
    4 / 136 (2.94%)
    9 / 201 (4.48%)
    7 / 219 (3.20%)
    8 / 212 (3.77%)
         occurrences all number
    3
    12
    4
    11
    7
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Oct 2011
    The purpose of this amendment was to • widen the scope of the inclusion/exclusion criteria to allow more patients to participate, especially in Asia. These changes did not substantially change the study population and did not have an impact on the risk benefit for the patients. To allow patients with no suitable validated ACD translation to participate in the study, as translations are not currently available for all countries and languages. The Asthma Control Diary in the trial was not a safety measure in this trial, since the patients’ safety on trial is monitored via the twice daily assessments recorded in the electronic diary. • to address some inconsistencies and errors in the text which were identified since the original submission.
    26 Mar 2012
    Due to the thorough QT (TQT) study (approximately 240 patients) that was performed in parallel with this study, ECG assessment in the current study was amended to reduce the patient burden. A2206 patients, who agreed to the extended PK sub-study, continued with comprehensive ECG assessment at all protocol defined time points, whereas, for the remainder of patients in study A2206 underwent, ECGs before predose and 1 hour post dose with optional ECGs at 3 and 6 hours post dose was retained while 3 and 6 hours post dose ECGs become optional.
    12 Oct 2012
    Due to lower than expected enrolment into the sputum sub-study, it was necessary to amend the protocol to allow patients to be placed into the restricted (1 of 3 treatment groups; QAW 450 mg qd, montelukast 10 mg qd and placebo) randomization list, even if they were not part of the sputum sub-study. This ensured that the total number of patients randomized to each of these three groups in the whole population remained at 125 in each group (to give 100 completers in each of these three groups, assuming a 20% dropout rate). In this way, sample size requirements for the primary endpoint analyses were met, without impact on the total number of patients required in the study.
    01 Feb 2013
    In order to assess the consistency in dose response between the Japanese and global populations, results from statistical modeling and simulations demonstrated that approximately 125 randomized Japanese patients should be included. This would provide a sample size of approximately 100 completed Japanese patients allowing for a 20% drop-out rate. Based on recruitment projections, additional time for recruitment in the clinical centers in Japan was required to allow for the requisite number of Japanese patients to be recruited. Therefore, to collect the planned Japanese sample size, continuation of Japanese enrollment and two database locks were performed. The first database lock was to be performed after approximately 950 randomized patients (including all patients, Japanese and non-Japanese) completed the study

    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
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