drugset / Trial / NCT00538057
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
RandomizedCrossoverDouble-blindTreatment
Summary
A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.
Timeline
- Start
- 2007-10-02
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
Publications
- Background This study has not been published in the scientific literature.
- Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 800 ug | Inhaled |
| Subject | GW642444M | Small molecule | 100 ug | — |