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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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 purpose of this study is to determine how well your asthma is controlled when taking one of the three treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SkyePharma AG
• Collaborators: Abbott; MDS Pharma Services
• Treatments: Fluticasone; Formoterol Fumarate; Xhance

Criteria

Main Inclusion Criteria:

• ≥ 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 Criteria:

• 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