Status:
COMPLETED
A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults
Lead Sponsor:
SkyePharma AG
Collaborating Sponsors:
Abbott
MDS Pharma Services
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 two medications in one inhaler. The...
Detailed Description
This Phase 3 randomized, double-blind, active-controlled, parallel group, stratified, multi-center study will evaluate the safety and efficacy of FlutiForm (250/10ug) after twice daily dosing over 12 ...
Eligibility Criteria
Inclusion
- Main
- ≥ Age 12 years at the Screening Visit.
- History of asthma for 12 months prior to the Screening Visit.
- Documented use of an inhaled corticosteroid for at least 4 weeks prior to the Screening Visit.
- Steroid-requiring patient
- patients must demonstrate (1) an FEV1 of 40% to 80% (inclusive) of predicted normal values at both the Screening and Baseline Visits and (2) documented reversibility within 12 months of the Screening Visit, defined as a ≥ 15%
- Main
Exclusion
- Life-threatening asthma within the past year or during the Run-In Period.
- History of systemic (oral or injectable) corticosteroid medication within 3 months before the Screening Visit.
- An upper or lower respiratory infection within 4 weeks prior to the Screening Visit or during the Run-In Period.
- Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
- A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
- Current smoking history within 12 months prior to the Screening Visit.
- Previous exposure to FlutiForm
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT00649025
Start Date
March 1 2008
End Date
October 1 2008
Last Update
August 27 2010
Active Locations (103)
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1
Investigational site
Scottsdale, Arizona, United States, 85251
2
Investigational Site
Tempe, Arizona, United States, 85282
3
Investigational Site
Encinitas, California, United States, 92024
4
Investigational site
Long Beach, California, United States, 90806