A Study on the Effects of a Single Dose of Prednisone on Biomarkers of Allergen Responses in Asthmatics (MK-0000-175)
Summary
The purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2) cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-05
- Completion
- 2011-05
Outcome
Met primary endpoint
registry Prednisone vs Placebo; p = 0.001; GM FR from Placebo: SP 0.25 (90% CI 0.14 to 0.46) NCT01193049 ↗
registry Prednisone vs Placebo; p <0.001; GM FR from Placebo : NE 0.20 (90% CI 0.13 to 0.30) NCT01193049 ↗
registry Prednisone vs Placebo; p = 0.009; GM FR from Placebo: SP 0.27 (90% CI 0.12 to 0.62) NCT01193049 ↗
registry Prednisone vs Placebo; p <0.001; GM FR from Placebo : NE 0.31 (90% CI 0.22 to 0.43) NCT01193049 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisone | Other / unclassified | 25 mg | Oral |