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

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

April 30, 2010

Conditions
Rhinitis, Allergic, SeasonalAsthma
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)

Trial Locations (1)

Unknown

1268.41.49001 Boehringer Ingelheim Investigational Site, Hanover

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY