Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma

Summary

The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.

Timeline

Start

2010-09-01

Primary completion

2011-08-01

Completion

2011-08-26

Outcome

Missed primary endpoint

registry Placebo vs Vilanteral 25 µg OD; p = 0.244; Mean Difference (Final Values) 0.070 (95% CI -0.048 to 0.188); NCT01181895 ↗

paper There were no statistically significant treatment differences between either the VI (70 ml, P = 0.244) or SAL (-6 ml, P = 0.926) groups and placebo. PMID 24928338 ↗

Publications

• Lotvall J, Bateman ED, Busse WW, O'Byrne PM, Woodcock A, Toler WT, Jacques L, Goldfrad C, Bleecker ER. Comparison of vilanterol, a novel long-acting beta2 agonist, with placebo and a salmeterol reference arm in asthma uncontrolled by inhaled corticosteroids. J Negat Results Biomed. 2014 Jun 13;13(1):9. doi: 10.1186/1477-5751-13-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Salmeterol	Other / unclassified	—	Oral
Subject	Vilanterol	Other / unclassified	—	Oral

Indications