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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled three-period incomplete cross over study to compare the efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis using an Environmental Exposure Chamber Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results.

    Summary
    EudraCT number
    		 2012-001389-14
    Trial protocol
    		 DE  
    Global end of trial date
    02 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CQAW039A2212
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01804400
    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
    02 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of QAW039 225 mg twice daily (b.i.d.) and Montelukast 10 mg once daily (q.d.) administered together as a free combination compared to QAW039 225 mg b.i.d monotherapy in patients with grass pollen-induced intermittent allergic rhinitis in an EEC challenge model. This was assessed by the Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched 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. After each challenge the subjects had an option to receive a Terbutaline Turbohaler as rescue medication.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2012
    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
    Germany: 188
    Worldwide total number of subjects
    188
    EEA total number of subjects
    188
    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)
    188
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study consisted of a maximum 49-day screening period including a 2-hour exposure to grass pollen in the Environmental Exposure Chamber (EEC).

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1
    Arm description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 2
    Arm description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 3
    Arm description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 4
    Arm description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 5
    Arm description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 6
    Arm description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Arm title
    		 Treatment Sequence 7
    Arm description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Arm title
    		 Treatment Sequence 8
    Arm description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 150 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule once daily in the morning and four capsules once daily in the evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 9
    Arm description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 10
    Arm description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Number of subjects in period 1
    		Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8 Treatment Sequence 9 Treatment Sequence 10
    Started
    19
    19
    18
    18
    19
    19
    19
    19
    19
    19
    Completed
    19
    19
    18
    17
    19
    19
    19
    18
    19
    19
    Not completed
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
         Subject withdrew consent
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Administrative problem
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    Period 2
    Period 2 title
    Washout Period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1
    Arm description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 2
    Arm description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 3
    Arm description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 4
    Arm description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 5
    Arm description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 6
    Arm description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 7
    Arm description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 8
    Arm description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 9
    Arm description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 10
    Arm description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8 Treatment Sequence 9 Treatment Sequence 10
    Started
    19
    19
    18
    17
    19
    19
    19
    18
    19
    19
    Completed
    19
    19
    18
    16
    18
    19
    19
    18
    19
    19
    Not completed
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
         Administrative problem
    -
    -
    -
    1
    1
    -
    -
    -
    -
    -
    Period 3
    Period 3 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1
    Arm description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In Treatment Period 1 this arm received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 2
    Arm description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Arm title
    		 Treatment Sequence 3
    Arm description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 150 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule once daily in the morning and four capsules once daily in the evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 4
    Arm description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 5
    Arm description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 150 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule once daily in the morning and four capsules once daily in the evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 6
    Arm description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 7
    Arm description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 8
    Arm description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 9
    Arm description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 10
    Arm description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Number of subjects in period 3
    		Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8 Treatment Sequence 9 Treatment Sequence 10
    Started
    19
    19
    18
    16
    18
    19
    19
    18
    19
    19
    Completed
    19
    19
    18
    16
    16
    19
    19
    18
    19
    19
    Not completed
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
         Administrative problem
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    Period 4
    Period 4 title
    Washout Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1
    Arm description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 2
    Arm description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 3
    Arm description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 4
    Arm description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 5
    Arm description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 6
    Arm description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 7
    Arm description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 8
    Arm description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 9
    Arm description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Sequence 10
    Arm description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8 Treatment Sequence 9 Treatment Sequence 10
    Started
    19
    19
    18
    16
    16
    19
    19
    18
    19
    19
    Completed
    19
    19
    18
    16
    16
    19
    18
    17
    19
    18
    Not completed
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
         Subject withdrew consent
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Abnormal lab value
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    Period 5
    Period 5 title
    Treatment Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment Sequence 1
    Arm description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Arm title
    		 Treatment Sequence 2
    Arm description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 3
    Arm description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 4
    Arm description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug E.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 5
    Arm description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 6
    Arm description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 150 mg capsules once daily in the morning

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One capsule once daily in the morning and four capsules once daily in the evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 7
    Arm description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Arm title
    		 Treatment Sequence 8
    Arm description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Investigational medicinal product name
    Placebo for QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Four capsules twice daily in the morning and evening

    Arm title
    		 Treatment Sequence 9
    Arm description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Placebo for montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule once daily in the evening

    Arm title
    		 Treatment Sequence 10
    Arm description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    QAW039
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Three 25 mg capsules and one 150 mg capsule administered twice daily in the morning and evening

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg capsule once daily in the evening

    Number of subjects in period 5
    		Treatment Sequence 1 Treatment Sequence 2 Treatment Sequence 3 Treatment Sequence 4 Treatment Sequence 5 Treatment Sequence 6 Treatment Sequence 7 Treatment Sequence 8 Treatment Sequence 9 Treatment Sequence 10
    Started
    19
    19
    18
    16
    16
    19
    18
    17
    19
    18
    Completed
    15
    16
    15
    13
    15
    17
    17
    16
    16
    16
    Not completed
    4
    3
    3
    3
    1
    2
    1
    1
    3
    2
         Subject withdrew consent
    -
    1
    -
    2
    -
    -
    -
    -
    -
    1
         Adverse event, non-fatal
    4
    2
    3
    1
    1
    2
    1
    -
    3
    -
         Administrative problem
    -
    -
    -
    -
    -
    -
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period 1
    Reporting group description
    		 All randomized subjects

    Reporting group values
    		 Treatment Period 1 Total
    Number of subjects
    		 188 188
    Age categorical
    Units: Subjects
        18-<65 years
    		 188 188
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ± 10.89 -
    Gender categorical
    Units: Subjects
        Female
    		 76 76
        Male
    		 112 112
    Subject analysis sets

    Subject analysis set title
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received both QAW039 225 mg and Montelukast twice daily for 2 weeks.

    Subject analysis set title
    QAW039 225 mg Twice Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received QAW039 225 mg twice daily for 2 weeks.

    Subject analysis set title
    Montelukast 10 mg Once Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received Montelukast once daily for 2 weeks.

    Subject analysis set title
    QAW039 450mg Once Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received QAW039 450 mg once daily for 2 weeks.

    Subject analysis set title
    Placebo Twice Daily
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received placebo twice daily for 2 weeks.

    Subject analysis sets values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy Montelukast 10 mg Once Daily Monotherapy QAW039 450mg Once Daily Monotherapy Placebo Twice Daily
    Number of subjects
    176
    107
    108
    68
    68
    Age categorical
    Units: Subjects
        18-<65 years
    176
    107
    108
    68
    68
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37 ± 10.9
    35.4 ± 10.25
    37.8 ± 11.14
    38.2 ± 11.71
    37 ± 10.82
    Gender categorical
    Units: Subjects
        Female
    70
    45
    38
    28
    30
        Male
    106
    62
    70
    40
    38

    End points

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    End points reporting groups
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 2
    Reporting group description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 3
    Reporting group description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 4
    Reporting group description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug B.

    Reporting group title
    Treatment Sequence 5
    Reporting group description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.

    Reporting group title
    Treatment Sequence 6
    Reporting group description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.

    Reporting group title
    Treatment Sequence 7
    Reporting group description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.

    Reporting group title
    Treatment Sequence 8
    Reporting group description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.

    Reporting group title
    Treatment Sequence 9
    Reporting group description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.

    Reporting group title
    Treatment Sequence 10
    Reporting group description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 2
    Reporting group description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 3
    Reporting group description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 4
    Reporting group description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 5
    Reporting group description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 6
    Reporting group description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 7
    Reporting group description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 8
    Reporting group description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 9
    Reporting group description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 10
    Reporting group description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In Treatment Period 1 this arm received Drug B.

    Reporting group title
    Treatment Sequence 2
    Reporting group description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.

    Reporting group title
    Treatment Sequence 3
    Reporting group description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.

    Reporting group title
    Treatment Sequence 4
    Reporting group description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug A.

    Reporting group title
    Treatment Sequence 5
    Reporting group description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.

    Reporting group title
    Treatment Sequence 6
    Reporting group description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 7
    Reporting group description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.

    Reporting group title
    Treatment Sequence 8
    Reporting group description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 9
    Reporting group description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 10
    Reporting group description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 2
    Reporting group description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 3
    Reporting group description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 4
    Reporting group description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 5
    Reporting group description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 6
    Reporting group description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 7
    Reporting group description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 8
    Reporting group description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 9
    Reporting group description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.

    Reporting group title
    Treatment Sequence 10
    Reporting group description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this washout period subjects did not receive drug.
    Reporting group title
    Treatment Sequence 1
    Reporting group description
    		 Treatment Sequence 1 = Drug A / Drug B / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.

    Reporting group title
    Treatment Sequence 2
    Reporting group description
    		 Treatment Sequence 2 = Drug A / Drug C / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug E.

    Reporting group title
    Treatment Sequence 3
    Reporting group description
    		 Treatment Sequence 3 was Drug A / Drug D / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.

    Reporting group title
    Treatment Sequence 4
    Reporting group description
    		 Treatment Sequence 4 = Drug B / Drug A / Drug E, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subject received Drug E.

    Reporting group title
    Treatment Sequence 5
    Reporting group description
    		 Treatment Sequence 5 = Drug B / Drug D / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 6
    Reporting group description
    		 Treatment Sequence 6 = Drug C / Drug A / Drug D, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug D.

    Reporting group title
    Treatment Sequence 7
    Reporting group description
    		 Treatment Sequence 7 = Drug C / Drug B / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Reporting group title
    Treatment Sequence 8
    Reporting group description
    		 Treatment Sequence 8 = Drug D / Drug A / Drug C, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug C.

    Reporting group title
    Treatment Sequence 9
    Reporting group description
    		 Treatment Sequence 9 = Drug E / Drug A / Drug B, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug B.

    Reporting group title
    Treatment Sequence 10
    Reporting group description
    		 Treatment Sequence 10 = Drug E / Drug C / Drug A, with A = QAW039 225 mg b.i.d plus Montelukast 10 mg q.d, B = QAW039 225 mg b.i.d, C = Montelukast 10 mg q.d, D = QAW039 450 mg q.d, E = Placebo b.i.d. In this treatment period subjects received Drug A.

    Subject analysis set title
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received both QAW039 225 mg and Montelukast twice daily for 2 weeks.

    Subject analysis set title
    QAW039 225 mg Twice Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received QAW039 225 mg twice daily for 2 weeks.

    Subject analysis set title
    Montelukast 10 mg Once Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received Montelukast once daily for 2 weeks.

    Subject analysis set title
    QAW039 450mg Once Daily Monotherapy
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received QAW039 450 mg once daily for 2 weeks.

    Subject analysis set title
    Placebo Twice Daily
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received placebo twice daily for 2 weeks.

    Primary: Change in Total Nasal Symptom Score (TNSS) From Baseline at 14 days

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    End point title
    		 Change in Total Nasal Symptom Score (TNSS) From Baseline at 14 days
    End point description
    Total Nasal Symptom Score (TNSS) was averaged over the last two hours (2-4hours) of exposure following 14 days treatment with QAW039 and/or Montelukast. The TNSS is a rating system of nasal symptoms, as assessed by the subject, of nasal congestion, rhinorrhea, nasal itch and sneezing, each of which is scored on a scale from 0 to 3 as follows: 0 - absent symptoms (no sign/symptoms evident); 1 - mild symptoms (sign symptom clearly present, but minimal awareness; easily tolerated); 2 - moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable); 3 - severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living). This results in a total nasal symptom score ranging between 0 and 12. A negative change from baseline indicates a treatment benefit. This endpoint analyzed the pharmacodynamic (PD) analysis set, which included all subjects with available PD data and no major protocol deviations.
    End point type
    Primary
    End point timeframe
    Baseline, Day 14
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy Montelukast 10 mg Once Daily Monotherapy QAW039 450mg Once Daily Monotherapy Placebo Twice Daily
    Number of subjects analysed
    168
    94
    104
    63
    64
    Units: score on a scale
        least squares mean (confidence interval 90%)
    -1.44 (-1.653 to -1.228)
    -1.344 (-1.616 to -1.072)
    -1.123 (-1.383 to -0.863)
    -0.878 (-1.206 to -0.549)
    -0.998 (-1.332 to -0.664)
    Statistical analysis title
    		 Analysis of TNSS
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 225 mg Twice Daily Monotherapy
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6019
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TNSS #2
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0091
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TNSS #3
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v Montelukast 10 mg Once Daily Monotherapy
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0742
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TNSS #4
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v Placebo Twice Daily
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0448
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TNSS #5
    Comparison groups
    QAW039 225 mg Twice Daily Monotherapy v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0526
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Total Ocular Symptom Score (TOSS) From Baseline at 14 days

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    End point title
    		 Change in Total Ocular Symptom Score (TOSS) From Baseline at 14 days
    End point description
    Total Ocular Symptom Score (TOSS), defined as the sum of ocular symptoms of eye tearing, itching, watery eyes and redness. redness, each of which is scored on a scale from 0 and 3 as below: 0 - absent symptoms (no sign/symptoms evident); 1 - mild symptoms (sign symptom clearly present, but minimal awareness; easily tolerated); 2 - moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable); 3 - severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living). This results in a total nasal symptom score ranging between 0 to 12. The lower TOSS values indicate less symptoms and a negative change from baseline indicates a treatment benefit. This endpoint analyzed the pharmacodynamic (PD) analysis set, which included all subjects with available PD data and no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    168
    94
    63
    Units: scores on a scale
        least squares mean (confidence interval 90%)
    -1.302 (-1.552 to -1.053)
    -1.338 (-1.649 to -1.026)
    -0.903 (-1.276 to -0.53)
    Statistical analysis title
    		 Analysis of TOSS
    Comparison groups
    QAW039 225 mg Twice Daily Monotherapy v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8597
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TOSS #2
    Comparison groups
    QAW039 225 mg Twice Daily Monotherapy v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0989
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of TOSS #3
    Comparison groups
    QAW039 450mg Once Daily Monotherapy v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0896
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Nasal Flow From Baseline at 14 days

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    End point title
    		 Change in Nasal Flow From Baseline at 14 days
    End point description
    Measured using rhinomanometry. Flow rates at 150 Pa were obtained separately for the right and left nostrils (cm^3/second). The sum of the flow rates of both nostrils was calculated from the two measurements. For nasal flow a treatment benefit is indicated by positive values for change from baseline. This endpoint analyzed the pharmacodynamic (PD) analysis set, which included all subjects with available PD data and no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Prior to, and every 60 min during allergen exposure period
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy Montelukast 10 mg Once Daily Monotherapy QAW039 450mg Once Daily Monotherapy Placebo Twice Daily
    Number of subjects analysed
    168
    94
    104
    63
    64
    Units: millilitres/second
        least squares mean (confidence interval 90%)
    65.868 (49.285 to 82.45)
    23.494 (1.624 to 45.364)
    39.66 (18.854 to 60.465)
    16.715 (-10.033 to 43.462)
    -13.663 (-40.911 to 13.586)
    Statistical analysis title
    		 Analysis of nasal flow
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 225 mg Twice Daily Monotherapy
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0075
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal flow #2
    Comparison groups
    Montelukast 10 mg Once Daily Monotherapy v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0854
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal flow #3
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0073
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal flow #4
    Comparison groups
    Placebo Twice Daily v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal flow #5
    Comparison groups
    QAW039 225 mg Twice Daily Monotherapy v Placebo Twice Daily
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0732
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal flow #6
    Comparison groups
    Placebo Twice Daily v Montelukast 10 mg Once Daily Monotherapy
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0085
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Nasal Excretion Weight From Baseline at 14 days

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    End point title
    		 Change in Nasal Excretion Weight From Baseline at 14 days
    End point description
    Total weight of tissues (before and after use). Tissue packs were supplied with all tissues collected to measure weight of nasal secretions. Subjects blew their noses prior to the completion of each collection period. For nasal secretion weight a treatment benefit is indicated by negative changes from baseline. This endpoint analyzed the pharmacodynamic (PD) analysis set, which included all subjects with available PD data and no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy Montelukast 10 mg Once Daily Monotherapy QAW039 450mg Once Daily Monotherapy Placebo Twice Daily
    Number of subjects analysed
    168
    94
    104
    63
    64
    Units: gram(s)
        least squares mean (confidence interval 90%)
    -1.212 (-1.558 to -0.865)
    -0.284 (-0.728 to 0.16)
    -0.619 (-1.042 to -0.196)
    -0.572 (-1.106 to -0.038)
    -0.147 (-0.691 to 0.398)
    Statistical analysis title
    		 Analysis of nasal secretion weight
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 225 mg Twice Daily Monotherapy
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0019
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal secretion weight #2
    Comparison groups
    Montelukast 10 mg Once Daily Monotherapy v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0382
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal secretion weight #3
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0652
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of nasal secretion weight #4
    Comparison groups
    Placebo Twice Daily v QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily
    Number of subjects included in analysis
    232
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0029
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at 14 days

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    End point title
    		 Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at 14 days
    End point description
    Change in FEV1 from Baseline. FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was calculated as the volume of air forcibly exhaled in one second. This endpoint analyzed the pharmacodynamic (PD) analysis set, which included all subjects with available PD data and no major protocol deviations.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 14
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy Montelukast 10 mg Once Daily Monotherapy QAW039 450mg Once Daily Monotherapy Placebo Twice Daily
    Number of subjects analysed
    168
    94
    104
    63
    64
    Units: litre(s)
        least squares mean (confidence interval 90%)
    0.01 (-0.008 to 0.028)
    -0.007 (-0.03 to 0.016)
    0.013 (-0.009 to 0.035)
    -0.012 (-0.04 to 0.016)
    -0.008 (-0.036 to 0.021)
    Statistical analysis title
    		 Analysis of FEV1
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 225 mg Twice Daily Monotherapy
    Number of subjects included in analysis
    262
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2842
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of FEV1 #2
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v Montelukast 10 mg Once Daily Monotherapy
    Number of subjects included in analysis
    272
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8482
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of FEV1 #3
    Comparison groups
    QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily v QAW039 450mg Once Daily Monotherapy
    Number of subjects included in analysis
    231
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2309
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of FEV1 #4
    Comparison groups
    QAW039 450mg Once Daily Monotherapy v QAW039 225 mg Twice Daily Monotherapy
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8027
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 Analysis of FEV1 #5
    Comparison groups
    QAW039 450mg Once Daily Monotherapy v Montelukast 10 mg Once Daily Monotherapy
    Number of subjects included in analysis
    167
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2161
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Plasma Concentration Maximum (Cmax)

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    End point title
    		 Plasma Concentration Maximum (Cmax)
    End point description
    Determined at steady state in plasma. Pharmacokinetic parameters were calculated from plasma concentration-time data using non-compartmental methods. This endpoint analyzed the pharmacokinetic (PK) analysis set, which included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    10
    8
    4
    Units: nanogram(s)/millilitre
        arithmetic mean (standard deviation)
    1170 ± 892
    1110 ± 550
    1890 ± 310
    No statistical analyses for this end point

    Secondary: Plasma Concentration Minimum (Cmin)

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    End point title
    		 Plasma Concentration Minimum (Cmin)
    End point description
    Determined at steady state in plasma. Pharmacokinetic parameters were calculated from plasma concentration-time data using non-compartmental methods. This endpoint analyzed the pharmacokinetic (PK) analysis set, which included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    10
    8
    4
    Units: nanograms/millilitre
        arithmetic mean (standard deviation)
    83.6 ± 32.2
    90.7 ± 60.3
    54.4 ± 29.5
    No statistical analyses for this end point

    Secondary: Plasma Concentration Average (Cav)

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    End point title
    		 Plasma Concentration Average (Cav)
    End point description
    Determined at steady state in plasma. Pharmacokinetic parameters were calculated from plasma concentration-time data using non-compartmental methods. This endpoint analyzed the pharmacokinetic (PK) analysis set, which included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    8
    8
    4
    Units: nanograms/millilitre
        arithmetic mean (standard deviation)
    325 ± 162
    308 ± 127
    300 ± 38.6
    No statistical analyses for this end point

    Secondary: Time of Cmax (Tmax)

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    End point title
    		 Time of Cmax (Tmax)
    End point description
    Determined at steady state in plasma. Pharmacokinetic parameters were calculated from plasma concentration-time data using non-compartmental methods. This endpoint analyzed the pharmacokinetic (PK) analysis set, which included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    10
    8
    4
    Units: hours
        median (full range (min-max))
    1.03 (0.55 to 3.97)
    1.47 (0.933 to 2)
    1.98 (0.55 to 2.02)
    No statistical analyses for this end point

    Secondary: Area Under Curve (AUCtau)

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    End point title
    		 Area Under Curve (AUCtau)
    End point description
    Determined at steady state in plasma. Pharmacokinetic parameters were calculated from plasma concentration-time data using non-compartmental methods. This endpoint analyzed the pharmacokinetic (PK) analysis set, which included all subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 QAW039 225 mg Twice Daily Plus Montelukast 10 mg Once Daily QAW039 225 mg Twice Daily Monotherapy QAW039 450mg Once Daily Monotherapy
    Number of subjects analysed
    8
    8
    4
    Units: hours*nanogram/millilitre
        arithmetic mean (standard deviation)
    3900 ± 1940
    3700 ± 1530
    7210 ± 926
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    QAW039 225 mg bid plus montelukast 10 mg qd
    Reporting group description
    		 QAW039 225 mg bid plus montelukast 10 mg qd

    Reporting group title
    QAW039 225 mg bid
    Reporting group description
    		 QAW039 225 mg bid

    Reporting group title
    Placebo bid
    Reporting group description
    		 Placebo bid

    Reporting group title
    QAW039 450 mg qd
    Reporting group description
    		 QAW039 450 mg qd

    Reporting group title
    Total (for all treatment periods)
    Reporting group description
    		 Total (for all treatment periods)

    Reporting group title
    montelukast 10 mg qd
    Reporting group description
    		 montelukast 10 mg qd

    Serious adverse events
    		 QAW039 225 mg bid plus montelukast 10 mg qd QAW039 225 mg bid Placebo bid QAW039 450 mg qd Total (for all treatment periods) montelukast 10 mg qd
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 176 (0.00%)
    0 / 107 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 188 (0.53%)
    1 / 108 (0.93%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Foetal death
         subjects affected / exposed
    0 / 176 (0.00%)
    0 / 107 (0.00%)
    0 / 68 (0.00%)
    0 / 68 (0.00%)
    1 / 188 (0.53%)
    1 / 108 (0.93%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         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 225 mg bid plus montelukast 10 mg qd QAW039 225 mg bid Placebo bid QAW039 450 mg qd Total (for all treatment periods) montelukast 10 mg qd
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    51 / 176 (28.98%)
    31 / 107 (28.97%)
    17 / 68 (25.00%)
    19 / 68 (27.94%)
    99 / 188 (52.66%)
    28 / 108 (25.93%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    28 / 176 (15.91%)
    22 / 107 (20.56%)
    9 / 68 (13.24%)
    6 / 68 (8.82%)
    61 / 188 (32.45%)
    16 / 108 (14.81%)
         occurrences all number
    36
    27
    13
    7
    103
    20
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    10 / 176 (5.68%)
    4 / 107 (3.74%)
    4 / 68 (5.88%)
    7 / 68 (10.29%)
    20 / 188 (10.64%)
    2 / 108 (1.85%)
         occurrences all number
    11
    4
    5
    8
    30
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 176 (7.39%)
    2 / 107 (1.87%)
    5 / 68 (7.35%)
    3 / 68 (4.41%)
    24 / 188 (12.77%)
    5 / 108 (4.63%)
         occurrences all number
    13
    2
    5
    3
    28
    5
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 176 (1.70%)
    1 / 107 (0.93%)
    3 / 68 (4.41%)
    2 / 68 (2.94%)
    10 / 188 (5.32%)
    2 / 108 (1.85%)
         occurrences all number
    3
    1
    3
    2
    11
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 176 (6.82%)
    11 / 107 (10.28%)
    1 / 68 (1.47%)
    5 / 68 (7.35%)
    36 / 188 (19.15%)
    7 / 108 (6.48%)
         occurrences all number
    12
    11
    1
    5
    37
    8

    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.
    Due to EudraCT system limitations, which EMA is aware of, results of crossover studies are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial 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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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