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Clinical trial

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

Read time: 3 mins
Last updated:3rd Dec 2015
Identifier: NCT02563067

Brief Summary:
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)

Detailed Description:
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.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Arms:
- Experimental:
QAW039 Dose 1
- Experimental: QAW039 Dose 2
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2019-08-27
Study type(s) Interventional
Expected enrolment 877
Study start date 2015-12-03
Estimated primary completion date 2019-07-04

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