drugset / Trial / NCT00354874

Investigation Of A New Medication (GW642444) In Asthmatic Patients

NCT00354874

Phase 2 Completed 28 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Timeline

Start
2005-01
Primary completion
2005-06
Completion
2005-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Salmeterol Other / unclassified 50 ug
Subject Vilanterol Other / unclassified 50 ug Inhaled
Subject Vilanterol Other / unclassified 100 ug Inhaled
Subject Vilanterol Other / unclassified 200 ug Inhaled

Indications