drugset / Trial / NCT00381667
Study to Assess GW642444 in Asthma Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |