Seasonal allergic rhinitis MedDRA version: 12.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Name: Dry extract BNO-1355 Coated Tablet
Product Code: BNO 1355
Pharmaceutical Form: Coated tablet
Other descriptive name: Dry extract of Galphimiae glaucae folium cum flore (DER 3-5:1), extra
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent including data protection declaration 2. Male or female outsubjects aged =18 and = 65 years 3. Minimum 2 years history of seasonal allergic rhinitis 4. Positive skin prick test to Dactylis glomerata within 12 months prior to or on visit 1 5. TNSS score of = 6 at least once during the 2h-baseline ECC exposure 6. FEV1 = 80 % pred (ESCS) at screening 7. BMI =18 and = 35 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: 1. Chronic and perennial allergic rhinitis 2. Upper or lower respiratory tract infection 4 weeks before visit 2. 3. Significant pulmonary disease other than allergic rhinitis or mild intermittent asthma managed by SABA alone 4. Immunisations or vaccinations within 4 weeks prior to inclusion 5. Anti-allergy immunotherapy (desensitizing with allergens) within the previous two years 6. History of chronic rhinosinusitis 7. History of polyposis nasi 8. Anatomical deviations of the nasal septum that significantly impair ventilation / airflow 9. Known hypersensitivity to study medication or excipients 10. Known diseases of hyperreactive immune activity or autoimmune response 11. Underlying diseases leading to significant immune deficiency 12. Treatment with systemic, topical, nasal or inhalative corticosteroids within the last 4 weeks prior to study inclusion 13. Treatment with oral H1-Antihistamines or cromoglycates within 72 hrs before study inclusions 14. Treatment with antiinflammatory analgesics, mucolytics / secretolytics, or alternative medicine preparations for treatment of common cold like symptoms or with immunomodulating properties within the last 7 days prior to study inclusion 15. Treatment with medication that might interfere with rescue medication for allergic shock (e.g. beta blocker, ACE blocker) 16. Subjects requiring immunosuppressive treatment for any condition at study entry 17. Severe diseases of liver or kidney 18. Severe somatopathic, neurological and / or psychiatric diseases 19. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse) 20. History of alcohol or drug abuse 21. Parallel participation in another study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study 22. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant, or presenting an unstable psychiatric history) 23. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the study 24. Subjects in custody by juridical or official order 25. Subjects who have difficulties in understanding the language (German) in which the subject information is given
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess both the acute and the prophylactic effect of 2 dosages of BNO-1355 in seasonal allergic rhinitis compared to placebo ;Secondary Objective: Not explicitly listed. For secondary endpoints and safety endpoints, see study protocol.;Primary end point(s): The mean of the Total Nasal Symptom Score (TNSS) triggered by allergen challenge for the interval of 2 - 4 hours afters start of the allergen challenge. | — |
Countries
Germany
Outcome results
None listed