CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 345 enrolled
Drug / intervention
QAW039 +3 moredrug
Likely dose
Fluticasone 250 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01836471
NCT01836471Phase 2Completed
CompareCT.gov

A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy

Novartis Pharmaceuticals·interventional·Posted Apr 22, 2013·Updated Mar 20, 2017

In Brief

A Phase 2 clinical trial evaluating QAW039, Placebo QAW039, and 2 other interventions for Asthma. Completed, enrolled 345 participants across 76 sites in 10 countries.

Detailed Summary

The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Colombia, Czechia, Germany, India, Poland, Romania, South Africa, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2013
Enrollment StartMay 1, 2013
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.2 years ago

Interventions

QAW039drug

QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)

Placebo QAW039drug

Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)

Fluticasone 250 mcgdrug

Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).

Fluticasone 100 mcgdrug

Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).