A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

Phase 3 Completed 1001 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.

Timeline

Start: 2012-12
Primary completion: 2014-02
Completion: 2014-02

Publications

Mahler DA, Kerwin E, Murray L, Dembek C. The Impact of Twice-Daily Indacaterol/Glycopyrrolate on the Components of Health-Related Quality of Life and Dyspnea in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):308-20. doi: 10.15326/jcopdf.6.4.2019.0131.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Glycopyrrolate	Small molecule	12.5 ug	Inhaled
Comparator	Indacaterol	Other / unclassified	27.5 ug	Inhaled
Subject	QVA149	Other / unclassified	12.5 ug	Inhaled
Subject	QVA149	Other / unclassified	27.5 ug	Inhaled

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation

Summary

Timeline

Publications

Drugs

Indications