Acute rhinosinusitis MedDRA version: 9.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis
Conditions
Interventions
Product Name: BNO-1016
Product Code: BNO-1016
Pharmaceutical Form: Coated tablet
Current Sponsor code: BNO-1016
Other descriptive name: Dry extract of a fixed combination of the following 5 herbal dru
Sponsors
Bionorica AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a 15 days treatment with a herbal medicinal product (BNO-1016) for treatment of acute rhinosinusitis in adult patients in two different dosages compared to placebo on the basis of the major symptom score (MSS) assessed by the investigator.;Secondary Objective: To assess the safety of two different dosages of BNO-1016 compared to placebo applied in patients with acute rhinosinusitis. To determine the dose with the best benefit / risk ratio for the treatment of acute rhinosinusitis.;Primary end point(s): The primary endpoint of this study is the MSS over the 15-day treatment period which will be calculated as “area under the curve” by the trapezoid rule. The MSS is the sum of the investigator’s morning assessment of the 5 main rhinosinusitis symptoms on Visit 1 (Day 0), Visit 2 (Day 3), Visit 3 (Day 7), Visit 4 (Day 10) and Visit 5 (Day 14) based on the 4-point rating scale given below: 0 = None / Not present 1 = Mild 2 = Moderate 3 = Severe The 5 main rhinosinusitis symptoms are: - rhinorrhea (anterior discharge) - postnasal drip - nasal congestion - headache - facial pain / pressure | — |
Countries
Germany
Outcome results
None listed