Overview

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

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Fluticasone
Montelukast
Xhance