Asthma Clinical Trial
Official title:
Randomised, Double-blind, Triple Dummy, Partial Cross-over (Each Active Treatment With Placebo) Study Using an Environmental Challenge Chamber (ECC) to Assess the Safety and Efficacy of 2 Weeks of Oral BI 671800 ED 50, 200 or 400 mg Bid, Compared to Montelukast 10 mg qd, Fluticasone Propionate Nasal Spray 200 µg qd (2 Nasal Actuations Each Nostril of 50 µg) Versus Placebo in Seasonal Allergic Rhinitis Patients Out of Season, Sensitive to Dactylis Glomerata.
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 671800 ED using three dose levels of BI 671800 ED (50 mg, 200 mg and 400 mg), administered twice daily compared to FP (fluticasone propionate) nasal 100 mcg per nostril qd in the morning or Montelukast 10 mg qd am given for 2 weeks in patients with SAR (seasonal allergic rhinitis) out of season using an environmental exposure chamber in patients known to be sensitive to the aero-allergen Dactylis glomerata.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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