Asthma, Rhinitis, Allergic, Seasonal
Conditions
Brief 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.
Interventions
DRUGBI 67100 ED 25 mg
2 capsules of BI 671800 ED 25 mg
DRUGBI 671800 ED placebo
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUGmontelukast placebo tablet
1 over-encapsulated montelukast placebo tablet (qd in the morning)
DRUGfluticasone propionate placebo nasal spray
fluticasone propionate placebo nasal spray (2 puffs each nostril qd in the morning)
DRUGBI 671800 ED 100 mg
4 capsules of BI 671800 ED 100 mg (bid in the morning and evening)
DRUG671800 ED placebo
2 capsules of BI 671800 ED placebo (bid in the morning and evening)
DRUGmontelukast 10 mg tablet
1 over-encapsulated montelukast 10 mg tablet (qd in the morning)
DRUGfluticasone propionate nasal spray placebo
fluticasone propionate nasal spray placebo (2 puffs each nostril qd in the morning)
DRUGFluticasonepropionate nasal spray 200 mcg
Fluticasonepropionate nasal spray 200 mcg (qd, 2 puffs of 50 mcg per nostril)
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent consistent with ICH-GCP guidelines (International Conference on Harmonisation for Good Clinical Practice) and local legislations prior to any study-related procedures, which includes medication washout and restrictions. 2. Male or female, with a diagnosis of seasonal allergic rhinitis by a physician with a positive skin prick test to Dactylis glomerata within 12 months prior to Visit 2 3. TNSS (total nasal symptom score) of less or equal than 2 before start of challenge at Visit 2 and a TNSS of \> 5 at least once during the 2h-baseline ECC exposure 4. 18 to 65 years of age (age inclusive) 5. Non-smoker or ex-smoker with a cigarette smoking history of less or equal than 10 pack-years (and smoking cessation for at least one year prior to enrolment) with negative urinary cotinine at screening (Visit 1) 6. Ability to comply with requirements, medication restrictions (see 4.2.2) and procedures of the study protocol including AM1® device and rescue medication use. 7. Pre-bronchodilator FEV1 (forced expiratory volume in one second) equal or greater than 80% of predicted value (European Community for Steel and Coal) at screening 8. BMI between 18 and 35 (Body Mass Index) 9. Negative breath -alcohol, urine -cotinine and -drug tests at screening (Visit 1)
Exclusion criteria
1. Significant pulmonary disease other than allergic rhinitis (or mild intermittent asthma managed by SABA (short acting bronchodilator) alone) or other medical conditions\* that may, in the opinion of the investigator result in the any of the following: * put the patient at risk because of participation in the study * influence the results of the study (as determined by medical history, examination and clinical investigations at screening) * cause concern regarding the patient's ability to participate in the study. \*e.g. cardiac, gastro-intestinal, hepatic, renal, metabolic, dermatologic, neurological, haematological, oncological and psychiatric. Patients with malignancy for which the patient has undergone resection, radiation or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed. 2. Any other nasal and sinusoidal diseases or conditions by discretion of the investigator (i.e. nasal polyps, frequent nose bleeding) which may influence the study results 3. Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Visit 1 or during the screening and baseline period. 4. Thoracotomy with pulmonary resection. 5. Previous participation in this study (receipt of randomized treatment) or active participation in a current interventional study. 6. Patients with a clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis at screening, if the abnormality defines a significant disease as defined in exclusion criterion No. 1. Patients will not be randomised if they have increased liver transaminases (AST or ALT greater than two fold the upper limit of normal at screening). Laboratory testing may be repeated once before randomization. 7. Significant alcohol or drug abuse within past 2 years (see
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | After 2 wks of active treatment compared to 2 wks treatment with placebo |
Secondary
| Measure | Time frame |
|---|---|
| Flow rate from rhinomanometry as AUC of values obtained at 2, 4 and 6 h | 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 | 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 | 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 | 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 | After 2 wks of active treatment compared to 2 wks treatment with placebo |
Countries
Germany
Outcome results
None listed