drugset / Trial / NCT00612820
A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)
RandomizedCrossoverDouble-blindTreatment
Summary
This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Timeline
- Start
- 2008-01
- Primary completion
- 2008-05
- Completion
- 2008-05
Publications
- Background This study has not been published in the scientific literature.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone propionate | Other / unclassified | 100 ug | Intranasal |
| Subject | Fluticasone propionate | Other / unclassified | 200 ug | Intranasal |
| Subject | GSK256066 | Small molecule | 200 ug | Intranasal |