A multi-centre, double-blind, placebo-controlled, randomised, parallel group study to assess the efficacy and safety of two different dosages of a herbal medicinal product (dry extract BNO-1016) in patients with acutre rhinosinusitisMulti-centre, double-blind, placebo-controlled, randomised, parallel group study

• Conditions: Acute rhinosinusitis; MedDRA version: 9.1Level: LLTClassification code 10052106Term: Rhinosinusitis

• Registration Number: EUCTR2008-002794-13-DE
• Lead Sponsor: Bionorica AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-17
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Signed informed consent including data protection declaration

2. Male and female outpatients aged =18 and = 75 years

3. Diagnosis of acute rhinosinusitis - characterized by a major symptom score* (MSS) =8 points (minimum 0, maximum 15 points) - confirmed by ultrasonography of paranasal sinuses -with presence of symptoms = 3 days prior to inclusion

*Out of the 5 main rhinosinusitis symptoms at least 3 must be present. Among these the presence of nasal congestion and facial pain / pressure is mandatory.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Chronic rhinosinusitis

2. Polyposis nasi

3. Cystic fibrosis

4. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow

5. Acute symptoms of allergic rhinitis

6. Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion

7. Known hypersensitivity to study medication or excipients

8. Underlying diseases leading to significant immune deficiency

9. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C, orbital complications, severe unilateral frontal headache or toothache)

10. Odontogenic sinusitis

11. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids (excluding inhaled corticosteroids for mild to moderate persistent asthma) within the last 4 weeks prior to study inclusion

12. Treatment with decongestant preparations, analgesics (except Paracetamol), mucolytics / secretolytics, antihistamines, or alternative medicine preparations for treatment of common coldlike symptoms or with immunomodulating properties within the last 7 days prior to study inclusion

13. Patients requiring antibiotic treatment for any condition at study entry

14. Pregnancy or lactation

15. Severe diseases of liver or kidney

16. Severe somatopathic, neurological and / or psychiatric diseases

17. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse)

18.History of alcohol or drug abuse

19. Parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study

20. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history

21. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study

22. Patients in custody by juridical or official order

23. Evidence of an uncooperative attitude

24. Patients who have difficulties in understanding the language (German) in which the patient information is given

Study & Design

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