drugset / Trial / NCT01245426

A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)

NCT01245426

Phase 2 Completed 136 enrolled GlaxoSmithKline
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.

Timeline

Start
2010-12
Primary completion
2011-07
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject GW870086 Small molecule 1 mg Inhaled
Subject GW870086 Small molecule 2 mg Inhaled
Subject GW870086 Small molecule 3 mg Inhaled
Subject GW870086 Small molecule 4 mg Inhaled

Indications