A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149

Summary

To demonstrate the non-inferiority of QVA149 110/50 µg o.d. to fluticasone/salmeterol 500/50 µg b.i.d. in terms of trough Forced Expiratory Volume in one second (FEV1) (mean of 23 hours 15 min and 23 hours 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD

Timeline

Start

2012-11

Primary completion

2014-02

Completion

2014-02

Outcome

Met primary endpoint

paper The primary objective of noninferiority between QVA149 and SFC in trough FEV1 at week 26 was met. PMID 26082625 ↗

paper QVA149 demonstrated statistically significant superiority to SFC for trough FEV1 (treatment difference [Δ]=75 mL; P<0.001). PMID 26082625 ↗

Publications

• Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Patalano F, Banerji D. Efficacy and Safety of Indacaterol/Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: The Chinese Cohort from the LANTERN Study. COPD. 2016 Dec;13(6):686-692. doi: 10.1080/15412555.2016.1182970. Epub 2016 Aug 11.
• Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Thach C, Patalano F, Banerji D; LANTERN Investigators. LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2015 Jun 5;10:1015-26. doi: 10.2147/COPD.S84436. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluticasone	Other / unclassified	500 ug	Inhaled
Subject	Glycopyrronium	Unknown	50 ug	Inhaled
Subject	Indacaterol	Other / unclassified	110 ug	Inhaled
Comparator	Salmeterol	Other / unclassified	50 ug	Inhaled

Indications