drugset / Trial / NCT02418468

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

NCT02418468

Phase 4 Completed 24 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This study compared the efficacy of indacaterol versus placebo in COPD patients classified as GOLD 2014 Patient Group B. This was a 2-arm parallel group study that recruited COPD patients classified by GOLD Patient Gorup B. On successful completion of run-in period, patients were randomized in the ratio 1:1 to receive prn salbutamol plus: 1. Indacaterol 150ug or 2. Placebo for indacaterol all once daily (od) for 26 weeks. The primary objective (trough FEV1) was assessed after 12 weeks.

Timeline

Start
2015-04-28
Primary completion
2016-04-19
Completion
2016-04-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Indacaterol Other / unclassified 150 ug Inhaled