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

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

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)

Sponsors & Collaborators

• Boehringer Ingelheim

  lead INDUSTRY

Principal Investigators

• Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2010-04-30

Countries

• Germany

Study Locations