drugset / Trial / NCT02449018

A Safety, Tolerability and Efficacy Study With QBW251 in COPD Patients With QBW251

NCT02449018 ↗

Phase 2 Completed 92 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the efficacy, safety and tolerability of multiple doses of QBW251 vs placebo administered orally, on airway function, lung volume, and quality of life in patients with chronic obstructive pulmonary disease (COPD)

Timeline

Start
2015-04-30
Primary completion
2016-12-27
Completion
2017-01-23

Outcome

Missed primary endpoint

registry analysis (superiority test); QBW251 vs Placebo; p = 0.130; Mean Difference (Net) 0.28 (90% CI -0.24 to 0.79); ANCOVA NCT02449018 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Icenticaftor Small molecule — Oral