Allergic rhinitis due to pollen MedDRA version: 12.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen
Conditions
Interventions
Product Name: BI 671800 ED 25 mg
Product Code: BI 671800 ED 25 mg
Pharmaceutical Form: Capsule*
Current Sponsor code: BI 671800
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions. - A diagnosis of seasonal allergic rhinitis by a physician and a positive skin prick test to Dactylis glomerata within 12 months prior to Visit 2 - TNSS of £ 2 before start of challenge at Visit 2 and a TNSS of > 5 at least once during the 2h-baseline ECC exposure - Male or female patients 18 to 65 years inclusive - Non-smokers or ex-smokers with a cigarette smoking history of = 10 pack-years* (and smoking cessation for at least one year prior to enrolment) - Ability to comply with requirements, medication restrictions and procedures of the study protocol including AM1® device and rescue medication use. - Pre-bronchodilator FEV1 = 80% predicted (ECSC) at screening - Body Mass Index (BMI) between = 18 and = 35 - Negative breath -alcohol, urine -cotinine and -drug tests at screening (Visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Significant pulmonary disease other than allergic rhinitis (or mild intermittent asthma managed by SABA alone) or other medical conditions* that may, in the opinion of the investigator result in the any of the following: a) put the patient at risk because of participation in the study, b) influence the results of the study (as determined by medical history, examination and clinical investigations at screening), c) 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. - 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 - Respiratory tract infection or asthma exacerbation in the 4 weeks prior to Visit 1 or during the screening and baseline period. - Thoracotomy with pulmonary resection. - Previous participation in this study (receipt of randomized treatment) or active participation in a current interventional study. - 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 an AST or ALT greater than two fold the upper limit of normal at screening. Laboratory testing may be repeated once before randomization. - Significant alcohol or drug abuse within past 2 years - Patients with known hypersensitivity to any component of the investigational treatment or to fluticasone propionate nasal spray or montelukast or salbutamol MDI or components. Patients taking CYP2C8 substrates such as - but not restricted to - amiodarone, amodiaquine, paclitaxel, rosiglitazone, pioglitazone, and repaglinide and CYP2C9 substrates such as - but not restricted to - warfarin, tolbutamide, phenytoin, losartan and acenocoumarol.- Patients who have been treated with specified medications in the given intervals before the respective Visit: Before Visit 2 An investigational drug within 1 month or six half lives (whichever is greater). Any immunomodulatory therapy since specific positive skin prick test. A biological based antagonist therapy including Omalizumab, or immune modulator therapy within 6 months A systemic (intravenous, intramuscular or oral) corticosteroid within 3 months The following medications within 4 weeks: topical steroids, change in prescription medications The following medications within 2 weeks: LABA, methylxanthines, leukotriene modifiers, any antihistamines, oral decongestants, any anti-rhinitis therapies (i.e., decongestants, herbals, anticholinergics), and hay-fever medications, tricyclic antidepressants, aspirin and any NSAID (for occasional pain relief, only paracetamol may be used), oral beta 2 agonists Before Visit 1: Short acting bronchodilator within 6 hours of baseline pulmonary function testing - Patients with a risk for prolonged QT interval effects including - A marked baseline prolongation of the QT interval by demonstration of a QTcB interval > 450 ms (confirmation by a repeated ECG, if necessary) - A history of additional risk factors for TdP (e.g., heart failure,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 bid, compared to fluticasone propionate (2 nasal actuations per nostril of 50 µg each) qd in the morning or montelukast (10 mg) qd in the morning given for 2 weeks in patients with SAR out of season using an ECC in patients known to be sensitive to the aero-allergen Dactylis glomerata;Secondary Objective: Population PK and biomarker assessments;Primary end point(s): The primary efficacy variable will be the Total Nasal Symptom Score (TNSS) as AUC of values obtained every 20 minutes over the entire period from 0-6h in the ECC | — |
Countries
Germany
Outcome results
None listed