Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Crossover Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma
This study is a multi-centre, randomised, double-blind, placebo-controlled (with rescue
medication), two period crossover study in subjects with persistent uncontrolled asthma,
currently not treated with an inhaled corticosteroid (ICS) or long acting beta 2 agonist
(LABA). This study is the first administration of GSK2269557 to asthmatic subjects, and the
aims of the study are to investigate the efficacy, safety, tolerability, and pharmacokinetics
of four weeks of treatment with orally inhaled GSK2269557 1000 microgram (mcg) in subjects
with persistent uncontrolled asthma. In a sub-study, biological mediators will be measured
from induced sputum and blood.
Approximately 50 subjects will be randomised into the study (including approximately 16
subjects in the sputum sub-study). Each subject will complete two treatment periods: subjects
will be randomised to receive GSK2269557 1000 mcg in one treatment period, and matching
placebo in the other treatment period. Each treatment will be administered once daily for 28
days (+/- 2 days) via the DISKUS™ dry powder inhaler (DPI).
The study will consist of a Screening Visit; a Run-in Period (approximately 2 weeks in
duration); two 28-day Treatment Periods (each with 4 clinic visits); a 4-week Washout Period
(between the Treatment Periods); and a Follow-up Visit. The total duration of the study for
each subject will be approximately 16 weeks. DISKUS is a registered trademark of the
GlaxoSmithKline group of companies.
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