drugset / Trial / NCT01709903
A 26-week Treatment Randomized, Double-blind, Double Dummy Study to Assess the Efficacy and Safety of QVA149
RandomizedParallel-groupQuadruple-blindTreatment
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
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 |