Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Phase 3 Completed 773 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Timeline

Start: 2012-04
Primary completion: 2013-12
Completion: 2013-12

Outcome

Met primary endpoint

paper GLY+SAL/FP demonstrated non-inferiority to TIO+SAL/FP for trough FEV1: least square mean treatment difference (LSMdiff) -7 mL (SE 17.4) with a lower limit for non-inferiority of -60 mL. PMID 25841237 ↗

Publications

Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glycopyrrolate	Small molecule	50 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled
Background	Fluticasone propionate	Other / unclassified	500 ug	Inhaled
Background	Salmeterol	Other / unclassified	50 ug	Inhaled