A randomized, double-blind, placebo-controlled, cross-over phase IIa/b study to assess the efficacy and safety of 2 dosages of a herbal medicinal product (dry extract BNO-1355) in patients with seasonal allergic rhinitis - BNO-1355 Allergic Rhinitis

• Conditions: Seasonal allergic rhinitis; MedDRA version: 12.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitis

• Registration Number: EUCTR2010-018786-33-DE
• Lead Sponsor: Bionorica SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>