Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
Condition: Rhinitis, Allergic, Seasonal; Asthma
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    


Intervention name(s): BI 67100 ED 25 mg; BI 671800 ED placebo; montelukast placebo tablet; montelukast placebo tablet; fluticasone propionate placebo nasal spray; fluticasone propionate placebo nasal spray; fluticasone propionate placebo nasal spray; BI 671800 ED 100 mg; BI 671800 ED placebo; BI 671800 ED placebo; BI 671800 ED placebo; BI 671800 ED 100 mg; 671800 ED placebo; montelukast placebo tablet; montelukast placebo tablet; montelukast placebo tablet; montelukast 10 mg tablet; fluticasone propionate placebo nasal spray; fluticasone propionate nasal spray placebo; Fluticasonepropionate nasal spray 200 mcg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 capsules of BI 671800 ED 25 mg; 2 capsules of BI 671800 ED placebo (bid in the morning and evening); 1 over-encapsulated montelukast placebo tablet (qd in the morning); 1 over-encapsulated montelukast placebo tablet (qd in the morning); fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning); fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning); fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning); 4 capsules of BI 671800 ED 100 mg (bid in the morning and evening); 4 capsules of BI 671800 ED placebo (bid in the morning and evening); 4 capsules of BI 671800 ED placebo (bid in the morning and evening); 4 capsules of BI 671800 ED placebo (bid in the morning and evening); 2 capsules of BI 671800 ED 100 mg (bid in the morning and evening); 2 capsules of BI 671800 ED placebo (bid in the morning and evening); 1 over-encapsulated montelukast placebo tablet (qd in the morning); 1 over-encapsulated montelukast placebo tablet (qd in the morning); 1 over-encapsulated montelukast placebo tablet (qd in the morning); 1 over-encapsulated montelukast 10 mg tablet (qd in the morning); fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning); fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning); Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)
Intervention MeSH terms: Fluticasone; Xhance; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment