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A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group, 6-Week Study to Evaluate the Effect of Multiple Doses of FlutiForm™ 250/10 Microgram HFA pMDI Twice Daily, FlutiForm™ 100/10 Microgram HFA pMDI Twice Daily, Prednisone and Placebo on the Hypothalmic-Pituitary-Adrenal Axis in Adult Subjects With Mild to Moderate Asthma.
The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of the two medications in one inhaler. The purpose of the study is to determine how the medication affects the amount, if any, of cortisol produced by the adrenal glands.
Details
| Lead sponsor | SkyePharma AG |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 160 |
| Start date | 2008-04 |
| Completion | 2008-09 |
Conditions
- Asthma
Interventions
- FlutiForm 250/10 ug
- FlutiForm 100/10 ug
- Oral Prednisone 10mg
- Placebo
Primary outcomes
- Investigate effect of SKP FlutiForm 250/10 ug HFA pMDI BID for 6 weeks, FlutiForm 100/10 ug HFA pMDI BID, 10 mg prednisone for 7 days, compared to Placebo on the hypothalamic-pituitary-adrenal (HPA) axis using measurement of 24-hours UFC — Baseline and Study days 42-43
Countries
United States