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CompletedNCT02555683Updated Oct 7, 2026Results posted

Efficacy and Safety Study of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

A Phase 3 interventional study of QAW039 and QAW039 in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 234 sites in 27 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Updated Oct 7, 2026Posted results revised66 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
894
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations:

  • patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population)
  • patients with inadequately controlled severe asthma (overall study population)

Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

Read the detailed description

This study used a randomized, multicenter, double-blind, placebo-controlled parallel-group design in which QAW039 150 mg or QA039 450 mg or placebo was added to standard of care, GINA steps 4 and 5 asthma therapy.

The study included:

  • Screening period of up to 2 weeks to assess eligibility;
  • Run-in period of approximately 2 weeks and a maximum of 6 weeks on placebo to collect baseline data for efficacy variables and compliance with the Electronic Peak Flow/ eDiary device. Upon completion of the run-in period, all patients who met the eligibility criteria were randomized to one of three treatments: QAW039 150 mg or QAW039 450 mg or placebo once daily in a ratio of 1:1:1.
  • Treatment period of 52 weeks (assessment period for all Primary and Secondary Outcome Measures). Clinic visits were scheduled approximately 4 weeks after randomization and then at approximately 8-week intervals during the active-treatment period. Phone calls occurred at specified time points between visits occurring at 8-week intervals. Patients who had successfully completed 52 weeks of treatment in this study were offered an optional participation in a safety study (CQAW039A2315).
  • Follow-up period of 4 weeks, investigational and drug-free, following the last dose of study drug. A follow-up visit occurred approximately 4 weeks (i.e., approximately 30 days) following the last dose of study therapy to complete safety assessments and pregnancy testing (if applicable). the follow-up period applied to all patients except those patients who had entered the safety study (CQAW039A2315) directly after the Week 52 study visit.
02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Asthma
  • QAW039
  • allergic asthma
  • allergy triggered asthma
  • reactive asthma
  • asthma attack
  • difficulty breathing
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 894 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent and assent (if applicable).
  • Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
  • A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to \<18 years
  • An ACQ score ≥1.5.
  • A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion criteria

Exclusion Criteria:

  • Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
  • Subjects who have participated in another trial of QAW039.
  • A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
  • History of malignancy with the exception of local basal cell carcinoma of the skin.
  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
894 participants (actual)

Study arms

  • Experimental
    QAW039 150 mg

    QAW039 150 mg once daily

    Drug: QAW039

  • Experimental
    QAW039 450 mg

    QAW039 450 mg once daily

    Drug: QAW039

  • Placebo comparator
    Placebo

    Placebo once daily

    Drug: Placebo

Interventions

  • DrugQAW039

    QAW039 150 mg once daily

  • DrugQAW039

    QAW039 450 mg once daily

  • DrugPlacebo

    Placebo once daily

06

What researchers measure

Primary outcomes

  1. Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation

    A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

    Time frame: Baseline, Week 52

  2. Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population

    A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation

    The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

    Time frame: 52 weeks

  2. Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation

    The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

    Time frame: Baseline, Week 52

  3. Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation

    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. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

    Time frame: Baseline, Week 52

  4. Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population

    The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life.

    Time frame: Baseline, Week 52

  5. Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population

    The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled).

    Time frame: Baseline, Week 52

  6. Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population

    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.

    Time frame: Baseline, Week 52

07

Results

Posted May 18, 2020

Participant flow

Participants were from Argentina, Australia, Austria, Belgium, Brazil, China, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Latvia, Lithuania, Philippines, Poland, Romania, Singapore, Spain, Switzerland, UK, US, Vietnam.

Participant flow — Overall Study
MilestoneQAW039 150 mgQAW039 450 mgPlacebo
Started301295298
Fas/saf: high eosinophil subpopulation200201201
Fas/saf: overall population299293298
Completed282278269
Not completed191729
Withdrew: Physician decision102
Withdrew: Lost to follow-up212
Withdrew: Technical problems110
Withdrew: Protocol deviation010
Withdrew: Lack of efficacy200
Withdrew: Death012
Withdrew: Adverse event101
Withdrew: Subject/guardian decision121222
Withdrew: Death post treatment/safety period010

Outcome measures

PrimaryRate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation

A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · events/year
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation
events/yearQAW039 150 mgQAW039 450 mgPlacebo
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in High Eosinophils Subpopulation0.97 (0.78 to 1.20)0.77 (0.62 to 0.97)0.93 (0.75 to 1.16)
Statistical analysis
  • QAW039 150 mg vs Placebo · negative binomial regression model · p = 0.800 (adjusted p-value) · Rate ratio: 1.04 · 95% CI 0.77 to 1.41Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · negative binomial regression model · p = 0.510 (adjusted p-value) · Rate ratio: 0.83 · 95% CI 0.61 to 1.14Adjusted p-values are based on the closed testing procedure
SecondaryChange From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation

The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Time frame:
52 weeks
Reported as:
Least squares mean · units on scale
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation
units on scaleQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in High Eosinophils Subpopulation0.75 ± 0.0670.81 ± 0.0670.68 ± 0.067
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.819 (adjusted p-value) · Mean difference (net): 0.08 · 95% CI -0.11 to 0.26Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.591 (adjusted p-vale) · Mean difference (net): 0.14 · 95% CI -0.05 to 0.32Adjusted p-values obtained from the closed testing procedure
SecondaryChange From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled). The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · units on scale
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation
units on scaleQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in High Eosinophils Subpopulation-0.88 ± 0.069-0.94 ± 0.069-0.76 ± 0.070
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.819 (adjusted p-value) · Mean difference (net): -0.12 · 95% CI -0.31 to 0.07Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.591 (adjusted p-value) · Mean difference (net): -0.17 · 95% CI -0.37 to 0.02Adjusted p-values obtained from the closed testing procedure
SecondaryChange From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation

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. The high eosinophils subpopulation consists of all patients with blood eosinophil count ≥ 250 cells/μL at baseline.

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · Liter
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation
LiterQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in High Eosinophils Subpopulation0.169 ± 0.02570.153 ± 0.02550.103 ± 0.0260
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.800 (adjusted p-value) · Mean difference (net): 0.067 · 95% CI -0.005 to 0.139Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.523 (adjusted p-value) · Mean difference (net): 0.050 · 95% CI -0.021 to 0.121Adjusted p-values obtained from the closed testing procedure
PrimaryRate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population

A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours\*); or death due to asthma. A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · events/year
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population
events/yearQAW039 150 mgQAW039 450 mgPlacebo
Rate of Moderate-to-severe Asthma Exacerbations During the 52-week Treatment Period in Overall Population0.92 (0.77 to 1.09)0.75 (0.62 to 0.90)0.96 (0.80 to 1.15)
Statistical analysis
  • QAW039 150 mg vs Placebo · negative binomial regression model · p = 0.819 (adjusted p-value) · Rate ratio: 0.96 · 95% CI 0.75 to 1.22Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · negative binomial regression model · p = 0.510 (adjusted p-value) · Rate ratio: 0.78 · 95% CI 0.61 to 1.01Adjusted p-values are based on the closed testing procedure
SecondaryChange From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population

The AQLQ+12 is comprised of a total of 32 individual questions that span a total of four domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The AQLQ+12 yields individual domain scores, which is the mean of all items in each domain, and an overall score, which is the mean of all 32 individual responses. Higher scores indicate less impairment in health-related quality of life.

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · units on scale
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population
units on scaleQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score in Overall Population0.68 ± 0.0530.73 ± 0.0540.61 ± 0.054
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.819 (adjusted p-value) · Mean difference (net): 0.08 · 95% CI -0.07 to 0.23Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.591 (adjusted p-vale) · Mean difference (net): 0.12 · 95% CI -0.03 to 0.27Adjusted p-values obtained from the closed testing procedure
SecondaryChange From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population

The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the ACQ-5 score is the mean of the 5 questions: therefore, between 0 (totally controlled) and 6 (severely uncontrolled).

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · units on scale
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population
units on scaleQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Asthma Control Questionnaire-5(ACQ-5) Score in Overall Population-0.83 ± 0.055-0.90 ± 0.056-0.71 ± 0.056
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.819 (adjusted p-value) · Mean difference (net): -0.11 · 95% CI -0.27 to 0.04Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.591 (adjusted p-value) · Mean difference (net): -0.19 · 95% CI -0.35 to -0.04Adjusted p-values obtained from the closed testing procedure
SecondaryChange From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population

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.

Time frame:
Baseline, Week 52
Reported as:
Least squares mean · Liter
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population
LiterQAW039 150 mgQAW039 450 mgPlacebo
Change From Baseline to Week 52 in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) in Overall Population0.144 ± 0.02050.108 ± 0.02060.068 ± 0.0209
Statistical analysis
  • QAW039 150 mg vs Placebo · ANCOVA · p = 0.819 (adjusted p-value) · Mean difference (net): 0.076 · 95% CI 0.019 to 0.134Adjusted p-values obtained from the closed testing procedure
  • QAW039 450 mg vs Placebo · ANCOVA · p = 0.591 (adjusted p-value) · Mean difference (net): 0.040 · 95% CI -0.017 to 0.097Adjusted p-values obtained from the closed testing procedure

Adverse events

Collected over Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 56 weeks.. Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
QAW039 150 mg0/299 (0%)33/299 (11%)204/299 (68.2%)
QAW039 450 mg1/293 (0.3%)30/293 (10.2%)193/293 (65.9%)
Placebo2/298 (0.7%)32/298 (10.7%)214/298 (71.8%)
Most frequent serious events
Showing 10 of 92
Most frequent serious events
EventQAW039 150 mgQAW039 450 mgPlacebo
AsthmaRespiratory, thoracic and mediastinal disorders10/2998/29314/298
PneumoniaInfections and infestations3/2995/2931/298
InfluenzaInfections and infestations1/2992/2931/298
Acute kidney injuryRenal and urinary disorders1/2992/2930/298
Viral upper respiratory tract infectionInfections and infestations2/2990/2930/298
Radius fractureInjury, poisoning and procedural complications2/2990/2930/298
Acute myocardial infarctionCardiac disorders0/2991/2930/298
Myocardial ischaemiaCardiac disorders0/2991/2930/298
Diverticulum intestinalGastrointestinal disorders0/2991/2930/298
GastritisGastrointestinal disorders0/2991/2930/298
Most frequent other events
Showing 10 of 14
Most frequent other events
EventQAW039 150 mgQAW039 450 mgPlacebo
AsthmaRespiratory, thoracic and mediastinal disorders151/299135/293155/298
NasopharyngitisInfections and infestations43/29937/29349/298
Upper respiratory tract infectionInfections and infestations35/29935/29331/298
BronchitisInfections and infestations29/29922/29326/298
Viral upper respiratory tract infectionInfections and infestations29/29926/29326/298
HeadacheNervous system disorders28/29922/29324/298
Upper respiratory tract infection bacterialInfections and infestations13/29914/29321/298
SinusitisInfections and infestations18/29919/29318/298
Urinary tract infectionInfections and infestations11/29915/29318/298
Back painMusculoskeletal and connective tissue disorders16/29916/29311/298

Baseline characteristics

Age, Continuous
Age, Continuous(years)QAW039 150 mgQAW039 450 mgPlaceboTotal
Mean49.9 ± 14.9751.1 ± 14.2950.3 ± 14.4850.4 ± 14.58
Sex: Female, Male
Sex: Female, Male(Participants)QAW039 150 mgQAW039 450 mgPlaceboTotal
Female192214177583
Male10981121311
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)QAW039 150 mgQAW039 450 mgPlaceboTotal
Caucasian214215213642
Black1161229
Asian453844127
Native American24292477
Unknown1236
Other65213
08

Study locations

234 sites
  • Novartis Investigative Site
    Birmingham, Alabama 35209, United States
  • Novartis Investigative Site
    Birmingham, Alabama 35249, United States
  • Novartis Investigative Site
    Gilbert, Arizona 85234, United States
  • Novartis Investigative Site
    Litchfield Park, Arizona 85340, United States
  • Novartis Investigative Site
    Peoria, Arizona 85381, United States
  • Novartis Investigative Site
    Little Rock, Arkansas 72209, United States
  • Novartis Investigative Site
    Hawaiian Gardens, California 90716, United States
  • Novartis Investigative Site
    Newport Beach, California 92663, United States
  • Novartis Investigative Site
    Redondo Beach, California 90277, United States
  • Novartis Investigative Site
    Riverside, California 92506, United States
  • Novartis Investigative Site
    Torrance, California 90503, United States
  • Novartis Investigative Site
    Westminster, California 92683, United States
  • Novartis Investigative Site
    New Haven, Connecticut 06520, United States
  • Novartis Investigative Site
    Brandon, Florida 33511, United States
  • Novartis Investigative Site
    New Smyrna Beach, Florida 32168, United States
  • Novartis Investigative Site
    Orlando, Florida 32803, United States
  • Novartis Investigative Site
    Orlando, Florida 32806, United States
  • Novartis Investigative Site
    Ormond Beach, Florida 32174, United States
  • Novartis Investigative Site
    Sebring, Florida 33870, United States
  • Novartis Investigative Site
    Winter Park, Florida 32789, United States
  • Novartis Investigative Site
    Gainesville, Georgia 30501, United States
  • Novartis Investigative Site
    Marietta, Georgia 30060, United States
  • Novartis Investigative Site
    Crowley, Louisiana 70526, United States
  • Novartis Investigative Site
    Zachary, Louisiana 70791, United States
  • Novartis Investigative Site
    Bangor, Maine 04401, United States
  • Novartis Investigative Site
    Gaithersburg, Maryland 20878, United States
  • Novartis Investigative Site
    White Marsh, Maryland 21162, United States
  • Novartis Investigative Site
    Livonia, Michigan 48152, United States
  • Novartis Investigative Site
    Ypsilanti, Michigan 48197, United States
  • Novartis Investigative Site
    Picayune, Mississippi 39466, United States
  • Novartis Investigative Site
    Bellevue, Nebraska 68123, United States
  • Novartis Investigative Site
    Lincoln, Nebraska 68510, United States
  • Novartis Investigative Site
    Omaha, Nebraska 68131, United States
  • Novartis Investigative Site
    Corning, New York 14830, United States
  • Novartis Investigative Site
    New York, New York 10016, United States
  • Novartis Investigative Site
    Charlotte, North Carolina 28277, United States
  • Novartis Investigative Site
    Gastonia, North Carolina 28054, United States
  • Novartis Investigative Site
    Monroe, North Carolina 28112, United States
  • Novartis Investigative Site
    New Bern, North Carolina 28562, United States
  • Novartis Investigative Site
    Whiteville, North Carolina 28472, United States
  • Novartis Investigative Site
    Wilmington, North Carolina 28401, United States
  • Novartis Investigative Site
    Winston-Salem, North Carolina 27103, United States
  • Novartis Investigative Site
    Canton, Ohio 44718, United States
  • Novartis Investigative Site
    Cincinnati, Ohio 45231, United States
  • Novartis Investigative Site
    Maumee, Ohio 43537, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73120, United States
  • Novartis Investigative Site
    Jefferson Hills, Pennsylvania 15025, United States
  • Novartis Investigative Site
    Pittsburgh, Pennsylvania 15213, United States
  • Novartis Investigative Site
    East Providence, Rhode Island 02941, United States
  • Novartis Investigative Site
    Boerne, Texas 78006, United States
  • Novartis Investigative Site
    McKinney, Texas 75069, United States
  • Novartis Investigative Site
    Plano, Texas 75093, United States
  • Novartis Investigative Site
    San Antonio, Texas 78229, United States
  • Novartis Investigative Site
    San Antonio, Texas 78251, United States
  • Novartis Investigative Site
    Fairfax, Virginia 22030, United States
  • Novartis Investigative Site
    CABA, Buenos Aires C1425BEN, Argentina
  • Novartis Investigative Site
    Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As C1425FVH, Argentina
  • Novartis Investigative Site
    San Miguel de Tucumán, Tucumán Province 4000, Argentina
  • Novartis Investigative Site
    Buenos Aires, C1012AAR, Argentina
  • Novartis Investigative Site
    Bedford Park, South Australia 5041, Australia
  • Novartis Investigative Site
    Clayton, Victoria 3168, Australia
  • Novartis Investigative Site
    Footscray, Victoria 3011, Australia
  • Novartis Investigative Site
    Heidelberg, Victoria 3084, Australia
  • Novartis Investigative Site
    Melbourne, Victoria 3004, Australia
  • Novartis Investigative Site
    Amstetten, Austria 3300, Austria
  • Novartis Investigative Site
    Feldkirch, Austria 6800, Austria
  • Novartis Investigative Site
    Graz, Austria 8036, Austria
  • Novartis Investigative Site
    Thalheim bei Wels, Austria 4600, Austria
  • Novartis Investigative Site
    Vienna, State of Vienna A-1140, Austria
  • Novartis Investigative Site
    Innsbruck, Tyrol 6020, Austria
  • Novartis Investigative Site
    Vienna, A 1090, Austria
  • Novartis Investigative Site
    Vienna, A-1130, Austria
  • Novartis Investigative Site
    Brussels, Belgium 1160, Belgium
  • Novartis Investigative Site
    Liège, Belgium 4000, Belgium
  • Novartis Investigative Site
    Genk, Limburg 3600, Belgium
  • Novartis Investigative Site
    Aalst, 9300, Belgium
  • Novartis Investigative Site
    Brussels, 1000, Belgium
  • Novartis Investigative Site
    Brussels, 1020, Belgium
  • Novartis Investigative Site
    Erpent, 5100, Belgium
  • Novartis Investigative Site
    Éghezée, 5310, Belgium
  • Novartis Investigative Site
    Herentals, 2200, Belgium
  • Novartis Investigative Site
    Kortrijk, 8500, Belgium
  • Novartis Investigative Site
    Ottignies, 1340, Belgium
  • Novartis Investigative Site
    Porto Alegre, Porto Alegre RS 90610 000, Brazil
  • Novartis Investigative Site
    Rio de Janeiro, Rio de Janeiro 21941-590, Brazil
  • Novartis Investigative Site
    Porto Alegre, Rio Grande do Sul 90020-090, Brazil
  • Novartis Investigative Site
    Blumenau, Santa Catarina 89030101, Brazil
  • Novartis Investigative Site
    Florianópolis, Santa Catarina 88040-970, Brazil
  • Novartis Investigative Site
    São Bernardo do Campo, São Paulo 09715 090, Brazil
  • Novartis Investigative Site
    São Paulo, São Paulo 04023-900, Brazil
  • Novartis Investigative Site
    São Paulo, São Paulo 05403 000, Brazil
  • Novartis Investigative Site
    São Paulo, São Paulo 05437 010, Brazil
  • Novartis Investigative Site
    Guangzhou, Guangdong 510120, China
  • Novartis Investigative Site
    Haikou, Hainan 570311, China
  • Novartis Investigative Site
    Shijiazhuang, Hebei 050000, China
  • Novartis Investigative Site
    Wuhan, Hubei 430030, China
  • Novartis Investigative Site
    Nanjing, Jiangsu 210006, China
  • Novartis Investigative Site
    Nanjing, Jiangsu 210009, China
  • Novartis Investigative Site
    Nanchang, Jiangxi 330006, China
  • Novartis Investigative Site
    Changchun, Jilin 130021, China

Showing the first 100 of 234 sites across 27 countries.

09

References and documents

Publications

  • Brightling CE, Gaga M, Inoue H, Li J, Maspero J, Wenzel S, Maitra S, Lawrence D, Brockhaus F, Lehmann T, Brindicci C, Knorr B, Bleecker ER. Effectiveness of fevipiprant in reducing exacerbations in patients with severe asthma (LUSTER-1 and LUSTER-2): two phase 3 randomised controlled trials. Lancet Respir Med. 2021 Jan;9(1):43-56. doi: 10.1016/S2213-2600(20)30412-4. Epub 2020 Sep 24. PubMed 32979986 ↗

Study documents

  • Study protocol · Feb 10, 2017
  • Statistical analysis plan · Nov 29, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

1 registry update since Sep 25, 2026
Results
Posted results revised
revised Oct 7, 2026
Sites
66 sites added, 65 sites removed
Show 66 added (7 Brazil, 6 Austria, 5 Belgium, 5 France, 3 Argentina, 2 China, 1 Estonia, 1 Germany, …)
  • Novartis Investigative Site · CABA, Argentina
  • Novartis Investigative Site · Ciudad Autonoma de Bs As, Argentina
  • Novartis Investigative Site · San Miguel de Tucumán, Argentina
  • Novartis Investigative Site · Amstetten, Austria
  • Novartis Investigative Site · Feldkirch, Austria
  • Novartis Investigative Site · Graz, Austria
  • Novartis Investigative Site · Thalheim bei Wels, Austria
  • Novartis Investigative Site · Vienna, Austria
  • Novartis Investigative Site · Vienna, Austria
  • Novartis Investigative Site · Brussels, Belgium
  • Novartis Investigative Site · Liège, Belgium
  • Novartis Investigative Site · Brussels, Belgium
  • Novartis Investigative Site · Brussels, Belgium
  • Novartis Investigative Site · Éghezée, Belgium
  • Novartis Investigative Site · Rio de Janeiro, Brazil
  • Novartis Investigative Site · Porto Alegre, Brazil
  • Novartis Investigative Site · Florianópolis, Brazil
  • Novartis Investigative Site · São Bernardo do Campo, Brazil
  • Novartis Investigative Site · São Paulo, Brazil
  • Novartis Investigative Site · São Paulo, Brazil
  • Novartis Investigative Site · São Paulo, Brazil
  • Novartis Investigative Site · Guangzhou, China
  • Novartis Investigative Site · Changchun, China
  • Novartis Investigative Site · Tartu, Estonia
  • Novartis Investigative Site · Montpellier, France
  • Novartis Investigative Site · Le Kremlin-Bicêtre, France
  • Novartis Investigative Site · Lyon, France
  • Novartis Investigative Site · Reims, France
  • Novartis Investigative Site · Strasbourg, France
  • Novartis Investigative Site · Heidelberg, Germany
  • …and 36 more on the registry record
Show 65 removed
  • Novartis Investigative Site · Caba, Argentina
  • Novartis Investigative Site · San Miguel de Tucuman, Argentina
  • Novartis Investigative Site · Ciudad Autonoma de Bs As, Argentina
  • Novartis Investigative Site · Amstetten, Austria
  • Novartis Investigative Site · Feldkirch, Austria
  • Novartis Investigative Site · Graz, Austria
  • Novartis Investigative Site · Thalheim bei Wels, Austria
  • Novartis Investigative Site · Wien, Austria
  • Novartis Investigative Site · Wien, Austria
  • Novartis Investigative Site · Brussel, Belgium
  • Novartis Investigative Site · Bruxelles, Belgium
  • Novartis Investigative Site · Bruxelles, Belgium
  • Novartis Investigative Site · Eghezee, Belgium
  • Novartis Investigative Site · Liege, Belgium
  • Novartis Investigative Site · Rio de Janeiro, Brazil
  • Novartis Investigative Site · Porto Alegre, Brazil
  • Novartis Investigative Site · Florianopolis, Brazil
  • Novartis Investigative Site · Sao Bernardo do Campo, Brazil
  • Novartis Investigative Site · Sao Paulo, Brazil
  • Novartis Investigative Site · Sao Paulo, Brazil
  • Novartis Investigative Site · Sao Paulo, Brazil
  • Novartis Investigative Site · Guang Zhou, China
  • Novartis Investigative Site · Chang Chun, China
  • Novartis Investigative Site · Tartu, Estonia
  • Novartis Investigative Site · Montpellier cedex 5, France
  • Novartis Investigative Site · Le Kremlin Bicetre, France
  • Novartis Investigative Site · Lyon Cedex 04, France
  • Novartis Investigative Site · Reims Cedex, France
  • Novartis Investigative Site · Strasbourg Cedex, France
  • Novartis Investigative Site · Heidelberg, Germany
  • …and 35 more on the registry record
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Posted results revised
    66 sites added, 65 sites removed
    Show 66 added (7 Brazil, 6 Austria, 5 Belgium, 5 France, 3 Argentina, 2 China, 1 Estonia, 1 Germany, …)
    • Novartis Investigative Site · CABA, Argentina
    • Novartis Investigative Site · Ciudad Autonoma de Bs As, Argentina
    • Novartis Investigative Site · San Miguel de Tucumán, Argentina
    • Novartis Investigative Site · Amstetten, Austria
    • Novartis Investigative Site · Feldkirch, Austria
    • Novartis Investigative Site · Graz, Austria
    • Novartis Investigative Site · Thalheim bei Wels, Austria
    • Novartis Investigative Site · Vienna, Austria
    • Novartis Investigative Site · Vienna, Austria
    • Novartis Investigative Site · Brussels, Belgium
    • Novartis Investigative Site · Liège, Belgium
    • Novartis Investigative Site · Brussels, Belgium
    • Novartis Investigative Site · Brussels, Belgium
    • Novartis Investigative Site · Éghezée, Belgium
    • Novartis Investigative Site · Rio de Janeiro, Brazil
    • Novartis Investigative Site · Porto Alegre, Brazil
    • Novartis Investigative Site · Florianópolis, Brazil
    • Novartis Investigative Site · São Bernardo do Campo, Brazil
    • Novartis Investigative Site · São Paulo, Brazil
    • Novartis Investigative Site · São Paulo, Brazil
    • Novartis Investigative Site · São Paulo, Brazil
    • Novartis Investigative Site · Guangzhou, China
    • Novartis Investigative Site · Changchun, China
    • Novartis Investigative Site · Tartu, Estonia
    • Novartis Investigative Site · Montpellier, France
    • Novartis Investigative Site · Le Kremlin-Bicêtre, France
    • Novartis Investigative Site · Lyon, France
    • Novartis Investigative Site · Reims, France
    • Novartis Investigative Site · Strasbourg, France
    • Novartis Investigative Site · Heidelberg, Germany
    • …and 36 more on the registry record
    Show 65 removed
    • Novartis Investigative Site · Caba, Argentina
    • Novartis Investigative Site · San Miguel de Tucuman, Argentina
    • Novartis Investigative Site · Ciudad Autonoma de Bs As, Argentina
    • Novartis Investigative Site · Amstetten, Austria
    • Novartis Investigative Site · Feldkirch, Austria
    • Novartis Investigative Site · Graz, Austria
    • Novartis Investigative Site · Thalheim bei Wels, Austria
    • Novartis Investigative Site · Wien, Austria
    • Novartis Investigative Site · Wien, Austria
    • Novartis Investigative Site · Brussel, Belgium
    • Novartis Investigative Site · Bruxelles, Belgium
    • Novartis Investigative Site · Bruxelles, Belgium
    • Novartis Investigative Site · Eghezee, Belgium
    • Novartis Investigative Site · Liege, Belgium
    • Novartis Investigative Site · Rio de Janeiro, Brazil
    • Novartis Investigative Site · Porto Alegre, Brazil
    • Novartis Investigative Site · Florianopolis, Brazil
    • Novartis Investigative Site · Sao Bernardo do Campo, Brazil
    • Novartis Investigative Site · Sao Paulo, Brazil
    • Novartis Investigative Site · Sao Paulo, Brazil
    • Novartis Investigative Site · Sao Paulo, Brazil
    • Novartis Investigative Site · Guang Zhou, China
    • Novartis Investigative Site · Chang Chun, China
    • Novartis Investigative Site · Tartu, Estonia
    • Novartis Investigative Site · Montpellier cedex 5, France
    • Novartis Investigative Site · Le Kremlin Bicetre, France
    • Novartis Investigative Site · Lyon Cedex 04, France
    • Novartis Investigative Site · Reims Cedex, France
    • Novartis Investigative Site · Strasbourg Cedex, France
    • Novartis Investigative Site · Heidelberg, Germany
    • …and 35 more on the registry record
    + 3 other changes: index terms, documents and identifiers

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT02555683
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 21, 2015
Start date
Dec 11, 2015
Primary completion
Oct 21, 2019
Completion
Nov 4, 2019
Results posted
May 18, 2020
Last update
Oct 7, 2026

Study contacts

Novartis Pharmaceuticals
study director · Novartis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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