NCT01007721

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Seasonal
• Asthma

Interventions

Type	Name	Description
DRUG	BI 67100 ED 25 mg	2 capsules of BI 671800 ED 25 mg
DRUG	BI 671800 ED placebo	2 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUG	montelukast placebo tablet	1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUG	montelukast placebo tablet	1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUG	fluticasone propionate placebo nasal spray	fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
DRUG	fluticasone propionate placebo nasal spray	fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
DRUG	fluticasone propionate placebo nasal spray	fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
DRUG	BI 671800 ED 100 mg	4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
DRUG	BI 671800 ED placebo	4 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUG	BI 671800 ED placebo	4 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUG	BI 671800 ED placebo	4 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUG	BI 671800 ED 100 mg	2 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
DRUG	671800 ED placebo	2 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUG	montelukast placebo tablet	1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUG	montelukast placebo tablet	1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUG	montelukast placebo tablet	1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUG	montelukast 10 mg tablet	1 over-encapsulated montelukast 10 mg tablet (qd in the morning)
DRUG	fluticasone propionate placebo nasal spray	fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
DRUG	fluticasone propionate nasal spray placebo	fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
DRUG	Fluticasonepropionate nasal spray 200 mcg	Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• First posted: 2009-11-04
• Last updated: 2014-05-16

Locations

1 site across 1 country: Germany