Trial intelligence / Profile preview

GSK256066 in Mild Asthma

NCT00380354Phase 2

Key facts

Status: Completed
Start: Sep 2006
Countries: 1
Sponsor: GSK
Modality: Small Molecules

Drugs: GSK256066
Conditions: asthma

Overview

Phase 2, randomised, double-blind trial in asthma comparing GSK256066 with Placebo (2 arms). Primary endpoint: Asthmatic response (Late Asthmatic Response) at 7 days. Started Sep 2006; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

GSK256066
Inhaled GSK256066 87.5 mcg once daily
Placebo
Matching placebo inhaler

Who it enrols

Adults aged 18-55 with mild asthma, FEV1 >75%, and a positive allergen skin test. Excludes smokers, history of cardiovascular disease, hayfever, or significant alcohol use.

Endpoints

Primary

Asthmatic response (Late Asthmatic Response)7 days

Secondary

Forced Expiratory Volume in 1 secondDay 8
Concentration of exhaled nitric oxideDay 8
Incidence of treatment emergent adverse eventsThroughout study

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