drugset / Trial / NCT00381667

Study to Assess GW642444 in Asthma Patients

NCT00381667

Phase 2 Completed 14 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients. Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.

Timeline

Start
2006-08
Primary completion
2007-01
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GW642444M Small molecule 25 ug Inhaled
Subject GW642444M Small molecule 100 ug Inhaled
Subject GW642444M Small molecule 400 ug Inhaled
Subject VILANTEROL .ALPHA.-PHENYL CINNAMATE Small molecule 100 ug