Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma
Phase 2
Completed
- Conditions
- Mild to Moderate Asthma
- Interventions
- Registration Number
- NCT00734292
- Lead Sponsor
- SkyePharma AG
- Brief Summary
The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Subjects with documented history of mild to moderate asthma currently taking a stable dose of inhaled corticosteroid
Exclusion Criteria
- Participation in a prior FlutiForm study
- Smoking history within the last 12 months,
- Significant, non-reversible, pulmonary disease
- Life-threatening asthma within the last year
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description II fluticasone propionate, formoterol fumarate * Period 1 Treatment Regimen B: FlutiForm 100/10 ug * Period 2 Treatment Regimen C: placebo * Period 3 Treatment Regimen A: FlutiForm 250/10 ug III fluticasone propionate, formoterol fumarate * Period 1 Treatment Regimen C: placebo * Period 2 Treatment Regimen A: FlutiForm 250/10 ug * Period 3 Treatment Regimen B: FlutiForm 100/10 ug I fluticasone propionate, formoterol fumarate * Period 1 Treatment Regimen A: FlutiForm 250/10 ug * Period 2 Treatment Regimen B: FlutiForm 100/10 ug * Period 3 Treatment Regimen C: placebo
- Primary Outcome Measures
Name Time Method Change from baseline FEV1 to post study drug dosing FEV1 3 minutes
- Secondary Outcome Measures
Name Time Method Change from baseline FEV1 to post study drug dosing FEV1 8, 15, 30, and 60 minutes
Trial Locations
- Locations (1)
Investigational Site
🇺🇸West Allis, Wisconsin, United States