Acute rhinosinusitis: with a rhinsinusitis symptom score >= 13 points (of maximal 25 points) using a 6 point-rating scala for the following symptoms which arose within up to 3 days prior to visit 1: Facial pain or pressure Anterior or posterior discharge or both Nasal congestion Reduced productivity Wake up at night MedDRA version: 9.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis
Conditions
Interventions
Trade Name: Wobenzym mono
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Bromelain
CAS Number: 9001-00-7
Current Sponsor co
Sponsors
MUCOS Pharma GmbH Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given their signed declaration of consent and data protection declaration 2. Males and females at the age of 18 – 70 years 3. Patients with a diagnosis of acute rhinosinusitis ·characterised by a rhinosinusitis symptom sum score = 13 points (minimum 0, maximum 25 points) using a 6-point rating scale for the following symptoms which arose within up to 3 days prior to visit 1: At visit 1 the patient will assess the rhinosinusitis symptoms for Day -1 in the evening (retrospectively) and for Day 0 in the morning. The rhinosinusitis symptom sum score is the sum of the mean scores each for - Facial pain or pressure sensation (Day -1, evening / Day 0, morning)* - Anterior or posterior discharge or both (Day -1, evening / Day 0, morning)* - Nasal congestion (Day -1, evening / Day 0, morning)* plus score for - Reduced productivity (Day -1, evening) - Wake up during night (Day 0, morning) and evaluated by ultrasonography of paranasal sinuses. * At least two of these 3 symptoms must be of at least moderate severity (score = 3). 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: Medical history and medications 1. Chronic rhinosinusitis with or without nasal polyps 2. Acute exacerbation of a chronic rhinosinusitis 3. History of surgery of paranasal sinuses 4. History or presence of type 1 allergy (e.g. allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma) 5. Non-allergic perennial rhinitis 6. Known intolerance against drug substance and / or excipient of the tablets (especially pineapple, lactose) 7. Pregnancy and /or lactation period 8. Current or participation in a clinical trial less than 30 days ago or participation in the same trial 9. Previous and concomitant medication like systemic, inhaled or nasal corticosteroids (beginning 4 weeks prior to visit 1), antibiotics, antihistamines, phytotherapeuticals and others for upper airway diseases incl. a-adrenergic agonists (beginning 7 day prior to visit 1) 10. Hemorrhagic diathesis 11. Concomitant medication likely to increase risk of bleeding (e.g. anticoagulants, platelet aggregation inhibitors) 12. History of palpitations 13. Severe diseases of liver or kidney; immunodeficiency, mucoviscidosis, asthma 14. Severe somatopathic, neurological and / or psychiatric diseases 15. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse) 16. History of alcohol and / or drug of abuse General 17. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 18. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study 19. Patients in custody by juridical or official order 20. Evidence of an uncooperative attitude (non-compliance) 21. Patients who have difficulties in understanding the language in which the patient information is given 22. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of a 14 days treatment with the pineapple enzyme preparation Wobenzym mono using three different dosages compared to placebo for the treatment of acute rhinosinusitis on the basis of 5 main rhinosinusitis symptoms assessed twice daily by the patient.;Secondary Objective: ·To determine the optimal dose with the best efficacy. ·To assess the safety of Wobenzym mono compared to placebo applied in patients with acute rhinosinusitis. ;Primary end point(s): The primary endpoint is: Time to relevant (50%) improvement of the rhinosinusitis symptom sum score. Each of the 5 individual symptoms will be rated in the diary by a 6-point rating scale. Due to a possible undulant course of the morning and evening sum score from day to day, the rhinosinusitis symptom sum score will be calculated using the scores of the morning and evening assessment in the following way: Mean scores of evening and subsequent morning assessment each for - Facial pain or pressure sensation - Anterior or posterior discharge or both - Nasal congestion plus score of evening assessment for - Reduced productivity plus score of subsequent morning assessment for - Wake up during night According to this procedure the baseline value of the rhinosinusitis symptoms sum score will be calculated from the assessments of Day -1 in the evening (retrospectively) and Day 0 in the morning (office assessments). | — |
Countries
Germany
Outcome results
None listed