drugset / Trial / NCT01836471

A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

NCT01836471 ↗

Phase 2 Completed 345 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-05
Primary completion
2016-02
Completion
2016-02

Outcome

Missed primary endpoint

registry QAW039 450 mg qd Non-atopic vs Placebo Non-atopic; p = 0.7269 NCT01836471 ↗

registry least squares mean 0.01 (90% CI -0.5 to 0.08) NCT01836471 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 100 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Subject fevipiprant Small molecule 450 mg Oral

Indications