Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

Phase 4 Completed 1053 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD

Timeline

Start: 2015-11-20
Primary completion: 2017-07-18
Completion: 2017-07-18

Outcome

Missed primary endpoint

paper reduction in trough FEV1 of -26 ml (95% confidence interval, -53 to 1 ml) with confidence limits exceeding the noninferiority margin of -50 ml. PMID 29779416 ↗

registry Mean Difference (Final Values) -0.026 (95% CI -0.053 to 0.001) NCT02603393 ↗

Publications

Chapman KR, Hurst JR, Frent SM, Larbig M, Fogel R, Guerin T, Banerji D, Patalano F, Goyal P, Pfister P, Kostikas K, Wedzicha JA. Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):329-339. doi: 10.1164/rccm.201803-0405OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	QVA149	Other / unclassified	50 ug	Inhaled
Subject	QVA149	Other / unclassified	110 ug	Inhaled
Comparator	Salmeterol/fluticasone	Unknown	50 ug	Inhaled
Comparator	Salmeterol/fluticasone	Unknown	500 ug	Inhaled
Comparator	Tiotropium	Other / unclassified	18 ug	Inhaled