drugset / Trial / NCT02233543

A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)

NCT02233543 ↗

Phase 4 Completed 38 enrolled Novartis Pharmaceuticals
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.

Timeline

Start
2014-11-30
Primary completion
2016-06-26
Completion
2016-06-26

Outcome

Missed primary endpoint

registry QVA149 (Indacaterol/Glycopyrronium) vs Placebo; p = 0.2419; Mean Difference (Net) -0.44 (95% CI -1.21 to 0.32) NCT02233543 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Glycopyrronium Unknown 43 ug Inhaled
Subject Indacaterol Other / unclassified 85 ug Inhaled