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    Clinical Trial Results:
    A 12-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to standard-of-care asthma therapy in patients with uncontrolled asthma

    Summary
    EudraCT number
    		 2017-001272-40
    Trial protocol
    		 SE   ES   BG   DE   HU   IT   RO  
    Global end of trial date
    01 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2020
    First version publication date
    16 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CQAW039A2317
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03226392
    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, Novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to demonstrate the efficacy of fevipiprant 150 mg once daily compared with placebo, as measured by change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) at the end of the 12-week active-treatment period
    Protection of trial subjects
    to demonstrate the efficacy of fevipiprant 150 mg once daily compared with placebo, as measured by change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) at the end of the 12-week active-treatment period
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 41
    Country: Number of subjects enrolled
    Bulgaria: 48
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Colombia: 28
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    India: 40
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 15
    Country: Number of subjects enrolled
    Peru: 91
    Country: Number of subjects enrolled
    Russian Federation: 109
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    United States: 186
    Country: Number of subjects enrolled
    Vietnam: 22
    Worldwide total number of subjects
    704
    EEA total number of subjects
    142
    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)
    13
    Adults (18-64 years)
    563
    From 65 to 84 years
    128
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from centers in Brazil (8), Bulgaria (4), Canada (3), Colombia (4), Germany (5), Hungary (7), India (5), Israel (5), Italy (4), Peru (6), Republic of Korea (5), Russian Federation (14), Spain (8), United States (36), Vietnam (3).

    Pre-assignment
    Screening details
    		 a Screening period of up to 2 weeks to assess eligibility during which patients practice completing the electronic peak expiratory flow eDiary/ePEF device.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 QAW039
    Arm description
    		 QAW039 once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fevipiprant
    Investigational medicinal product code
    QAW039
    Other name
    QAW039
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150mg tablet

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    tablets

    Number of subjects in period 1 [1]
    		QAW039 Placebo
    Started
    352
    350
    Completed
    341
    344
    Not completed
    11
    6
         Physician decision
    1
    -
         Protocol Deviation
    1
    -
         Adverse event, non-fatal
    1
    -
         Subject/Guardian Decision
    7
    6
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2 patients in the placebo were mis-randomized, not treated, not included due to “technical problems

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QAW039
    Reporting group description
    		 QAW039 once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Reporting group values
    		 QAW039 Placebo Total
    Number of subjects
    		 352 350 702
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 7 6 13
        Adults (18-64 years)
    		 275 286 561
        From 65-84 years
    		 70 58 128
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 50.4 ± 14.87 50.2 ± 14.39 -
    Sex: Female, Male
    Units:
        Female
    		 216 218 434
        Male
    		 136 132 268
    Race/Ethnicity, Customized
    Units: Subjects
        Black
    		 26 18 44
        Asian
    		 41 46 87
        Native American
    		 12 12 24
        Pacific Islander
    		 2 0 2
        Other
    		 55 58 113
        Caucasian
    		 216 216 432

    End points

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    End points reporting groups
    Reporting group title
    QAW039
    Reporting group description
    		 QAW039 once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily

    Primary: Change from baseline in pre-dose FEV1

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    End point title
    		 Change from baseline in pre-dose FEV1
    End point description
    Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    352
    350
    Units: Liters
        least squares mean (standard error)
    0.126 ± 0.00177
    0.157 ± 0.0177
    Statistical analysis title
    		 change from baseline in pre-dose FEV1
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.214
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.031
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.018

    Secondary: Change from baseline in daytime asthma symptom score

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    End point title
    		 Change from baseline in daytime asthma symptom score
    End point description
    Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    352
    350
    Units: Score
        least squares mean (standard error)
    -0.55 ± 0.034
    -0.45 ± 0.034
    Statistical analysis title
    		 change in mean daytime asthma symptom
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.035
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 0.04%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.01

    Secondary: Change from baseline in number of puffs of SABA taken per day

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    End point title
    		 Change from baseline in number of puffs of SABA taken per day
    End point description
    Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily – at the same time each morning and each evening, approximately 12 hours apart.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    352
    350
    Units: Number of puffs
        least squares mean (standard error)
    -0.89 ± 0.066
    -0.88 ± 0.066
    Statistical analysis title
    		 change in mean total daily use of SABA
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.893
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.17

    Secondary: Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score

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    End point title
    		 Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score
    End point description
    AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated "better quality of life." Overall AQLQ+12 score is the mean of all 32 responses
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 QAW039 Placebo
    Number of subjects analysed
    352
    350
    Units: units on a scale
        least squares mean (standard error)
    0.77 ± 0.043
    0.72 ± 0.043
    Statistical analysis title
    		 change from baseline in AQLQ+12
    Comparison groups
    QAW039 v Placebo
    Number of subjects included in analysis
    702
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.448
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.061
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.17

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After signing informed consent to 30 days after last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    QAW039 150 mg
    Reporting group description
    		 QAW039 150 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 QAW039 150 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 352 (1.99%)
    3 / 350 (0.86%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 352 (0.00%)
    1 / 350 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 352 (0.85%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 352 (0.28%)
    0 / 350 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 QAW039 150 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 352 (26.70%)
    116 / 350 (33.14%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 352 (0.00%)
    5 / 350 (1.43%)
         occurrences all number
    0
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 352 (1.42%)
    14 / 350 (4.00%)
         occurrences all number
    5
    15
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    46 / 352 (13.07%)
    61 / 350 (17.43%)
         occurrences all number
    56
    79
    Cough
         subjects affected / exposed
    2 / 352 (0.57%)
    5 / 350 (1.43%)
         occurrences all number
    2
    7
    Dyspnoea
         subjects affected / exposed
    3 / 352 (0.85%)
    5 / 350 (1.43%)
         occurrences all number
    5
    7
    Oropharyngeal pain
         subjects affected / exposed
    6 / 352 (1.70%)
    4 / 350 (1.14%)
         occurrences all number
    6
    4
    Rhinitis allergic
         subjects affected / exposed
    3 / 352 (0.85%)
    5 / 350 (1.43%)
         occurrences all number
    3
    5
    Wheezing
         subjects affected / exposed
    1 / 352 (0.28%)
    4 / 350 (1.14%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    7 / 352 (1.99%)
    7 / 350 (2.00%)
         occurrences all number
    7
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    9 / 352 (2.56%)
    6 / 350 (1.71%)
         occurrences all number
    9
    6
    Influenza
         subjects affected / exposed
    4 / 352 (1.14%)
    1 / 350 (0.29%)
         occurrences all number
    4
    1
    Nasopharyngitis
         subjects affected / exposed
    10 / 352 (2.84%)
    24 / 350 (6.86%)
         occurrences all number
    10
    27
    Pharyngitis
         subjects affected / exposed
    5 / 352 (1.42%)
    2 / 350 (0.57%)
         occurrences all number
    5
    2
    Respiratory tract infection viral
         subjects affected / exposed
    5 / 352 (1.42%)
    1 / 350 (0.29%)
         occurrences all number
    5
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 352 (1.99%)
    10 / 350 (2.86%)
         occurrences all number
    7
    10
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    3 / 352 (0.85%)
    6 / 350 (1.71%)
         occurrences all number
    3
    6
    Viral upper respiratory tract infection
         subjects affected / exposed
    12 / 352 (3.41%)
    8 / 350 (2.29%)
         occurrences all number
    13
    10

    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.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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