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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
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)
1268.41.49001 Boehringer Ingelheim Investigational Site
Hanover, Germany
Total Nasal Symptom Score (TNSS) as AUC (area under the curve) of values over the entire period from 0-6 hours (h) in the ECC (Environmental Challenge Chamber)
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
Total Symptom Score (TSSc) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax-6h and hourly
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
TNSS as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6; 0h-tmax; tmax-6h and hourly
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
Total Ocular Symptom Score (TOSS) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax- 6h and hourly
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
Nasal and ocular sub-scores (single symptoms of TNSS and TOSS) as AUC of values for the following periods: 0-2h; 2-4h; 4-6h; 2-6h; 0-6h; 0h-tmax; tmax-6h and hourly
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
Flow rate from rhinomanometry as AUC of values obtained at 2, 4 and 6 h
Time frame: After 2 wks of active treatment compared to 2 wks treatment with placebo
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