Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.
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This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma)
Condition or disease
Drug: QAW039Drug: Placebo
A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In addition, asthma quality of life score, asthma control score and lung function will be assessed. Safety will be assessed by adverse event monitoring.
A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
Actual Study Start Date :
December 3, 2015
Actual Primary Completion Date :
July 4, 2019
Actual Study Completion Date :
August 2, 2019
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Moderate-to-severe asthma exacerbations [ Time Frame: 52 weeks ]
Reduction in the rate of moderate-to-severe asthma exacerbations. 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)
Secondary Outcome Measures :
Asthma Quality of Life Questionnaire+12 (AQLQ+12) score [ Time Frame: 52 weeks ]
Change from baseline in AQLQ+12 score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment.
Asthma Control Questionnaire-5 (ACQ-5) score [ Time Frame: 52 weeks ]
Change from baseline in ACQ-5 score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment).
Pre-dose Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 52 weeks ]
Change from baseline in pre-dose FEV1 (liters).
Safety (Incidence of Treatment-Emergent Adverse Events) [ Time Frame: 52 weeks ]
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent.
Male and female patients aged ≥12 years.
A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 ≤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.
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.
Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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