Effects of a combination of umeclidinium/vilanterol on exercise endurance in patients with chronic obstructive pulmonary disease: two randomized, double-blind clinical trials.

Abstract

OBJECTIVE:

Exercise intolerance is a hallmark of chronic obstructive pulmonary disease (COPD).

METHODS:

Patients with COPD were randomized in two multicentre, double-blind, incomplete block crossover studies. Patients received two of six treatments in sequence (12 weeks each): placebo, umeclidinium (UMEC)/vilanterol (VI) (125/25 mcg or 62.5/25 mcg), VI (25 mcg) or UMEC (62.5 mcg or 125 mcg). Exercise endurance time (EET) and trough forced expiratory volume in 1 second (FEV1) (Week 12) were co-primary endpoints. Safety was monitored throughout.

RESULTS:

Both studies showed similar 3-hour post-dose EET improvements from baseline for UMEC/VI (Week 12). Significant EET improvements were observed with both UMEC/VI doses versus placebo at Week 12 in Study 418 (UMEC/VI 125/25 mcg: 65.8 s; p = 0.005; UMEC/VI 62.5/25 mcg: 69.4 s; p = 0.003), but not in Study 417, where a placebo effect was evident. Post hoc integrated data analysis showed significant but smaller EET improvements for both UMEC/VI doses versus placebo at Week 12 (UMEC/VI 125/25 mcg: 47.5 s; p = 0.002; UMEC/VI 62.5/25 mcg: 43.7 s; p = 0.001). Both studies showed trough FEV1 improvements at Week 12 for both UMEC/VI doses. The incidence of adverse events was similar between treatment groups within each study.

CONCLUSIONS:

UMEC/VI improved lung function and EET.

• Authors: François Maltais, Sally Singh, Alison C Donald, Glenn Crater, Alison Church, Aik H Goh, John H Riley
• Journal: Therapeutic advances in respiratory disease (Ther Adv Respir Dis) Vol. 8 Issue 6 Pg. 169-81 (Dec 2014) ISSN: 1753-4666 [Electronic] England
• PMID: 25452426 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s), 2014.

Chemical References

• Benzyl Alcohols
• Chlorobenzenes
• GSK573719
• Quinuclidines
• vilanterol

Topics

• Benzyl Alcohols (administration & dosage)
• Chlorobenzenes (administration & dosage)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Follow-Up Studies
• Forced Expiratory Volume
• Humans
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (drug therapy, physiopathology)
• Quinuclidines (administration & dosage)
• Treatment Outcome