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

Phase 3

Completed

• Conditions: Asthma

• Registration Number: JPRN-jRCT2080223052
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-22
• Study Completion: 2019-08-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

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 of >=40% and <=80% of the predicted normal value.
-An ACQ score >=1.5.
-A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

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 >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Moderate-to-severe asthma exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>Reduction in the rate of moderate-to-severe asthma exacerbations.

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Asthma Quality of Life Questionnaire+12 (AQLQ+12) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br>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.<br><br>efficacy<br>Asthma Control Questionnaire-5 (ACQ-5) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br><br>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).<br><br><br><br>efficacy<br>Pre-dose Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]<br><br>Change from baseline in pre-dose FEV1 (liters).<br>safety<br>Safety (Incidence of Treatment-Emergent Adverse Events) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]