Single Dose Study of the Fluticasone/Salmeterol (500/50 μg) Administered With Elpenhaler® Versus Diskus®

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

Summary

The aim of this study is to establish the therapeutic equivalence between the test (Fluticasone/Salmeterol administered with Elpenhaler®, Rolenium®) and the reference formulation (Seretide®, administered with Diskus®), both containing 500/50μg of the Fluticasone/Salmeterol combination.

The study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.

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

Details

• Lead Sponsor: Elpen Pharmaceutical Co. Inc.
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• age 18-65 years,

• diagnosis of asthma of 6 months,

• FEV1 ≥ 50% and ≤ 80% predicted,

• reversibility of at least 12%,

• stable asthma for at least 4 weeks,

• inhaled steroids (ICS) at a stable dose within the previous 30 days,

• PIF 30 - 90 lt/min and

• informed consent.

Exclusion Criteria:

• history of other pulmonary disease,

• asthma exacerbation or respiratory infection within the previous 4 weeks,

• hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase, within the previous 30 days,

• heavy smokers,

• change of asthma medication within the previous 4 weeks,

• seasonal asthma alone,

• history of severe heart disease,

• pregnancy or lactation,

• use of a β-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.