Patients suffering from chronic rhinosinusitis
Conditions
Interventions
Trade Name: Bromelaintabletten hysan
Product Name: Bromelaintabletten hysan
Pharmaceutical Form: Gastro-resistant tablet
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administr
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients with chronic rhinosinusitis (=symptomatology more than 12 weeks without complete remission) diagnosed by the physician after a endoscopic and pre-existing CT examination (CT results have to be available from within the last 12 months) •Patients with characteristic symptoms according to EPOS guidelines composed of two or more symptoms which have been diagnosed by a rhinoscopic and ENT-specific examination by the physician. One of these symptoms has to be either nasal obstruction or nasal discharge (anterior/posterior rhinorrhea) ± facial pain or facial pressure respectively headache ± loss of smell or change in perceptions of smell. The Rhinosinusitis Symtome Score (RSSS) must be = 6. •Compliance and ability of the patient to follow the study protocol and to complete a diary card for self-evaluation of the symptoms and antisymptomatic medication, •Female or male patients aged 18–75 years •Signed and dated patient´s Informed Consent 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •Simultaneous participation in other clinical trials or previous participation within 60 days before inclusion •Patients with polyposis nasi (no exclusion criterium in follow-up visits V2 – V5) •Patients with a surgical intervention of the paranasal sinus within the last six months •Patients with drug therapy of chronic rhinosinusitis within the last 30 days (with oral, intranasal or parenteral antibiotics and/or intranasal or systemic corticoids). •Patients requiring non steroidal anti-inflammatory drugs •Symptoms caused predominantly by allergic rhinitis •Known allergy to components of the study product •Patients being in any relationship or dependency with the sponsor and/or investigator •Other reasons contraindicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions, serious concomitant disease) •Malignancy •Inability to understand instructious/study documents •Female patients who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (see Annex XX.3) •Patients with coagulation disorder •Patients with neurological disease e.g. multiple sclerosis •Patients requiring anticoagulation or thrombocyte aggregation inhibitors •Alcohol abuse as well as drug and/or medication abuse •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs •Patients treated with contra-indicated drugs. •Unreliable patients including non-compliant patients •Patients with a history of a serious psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of Bromelain tablets hysan® by the Total Rhinosinusitis Rescue Medication Score (TRSSRMS) taking in account the Rhinosinusitis Symptom Score (RSSS) of the four rhinosinusitis symptoms (nasal obstruction, nasal discharge, facial pain or facial pressure and reduction or loss of smell) and the Rescue Medication Score (RMS). ;Secondary Objective: The secondary objectives are the evaluation of the clinical benefit of Bromelain tablets hysan® by means of reduction of rhinosinusitis symptoms (nasal obstruction, nasal discharge, facial pain/pressure, reduction or loss of smell) during the treatment period, evaluation of the Peak Nasal Inspiratory Flow (PNIF), the evaluation of the Quality of life by the Sino-Nasal Outcome Test German Adapted Version Questionnaire (SNOT-20 GAV), nasal rhinoscopic inspection with optics (edema, secretion and redness), and cytokine analysis.;Primary end point(s): The primary endpoint is to assess the efficacy of Bromelain tablets hysan® by the Total Rhinosinusitis Rescue Medication Score (TRSSRMS) taking in account the Rhinosinusitis Symptom Score (RSSS) of the four rhinosinusitis symptoms (nasal obstruction, nasal discharge, facial pain or facial pressure and reduction or loss of smell) and the Rescue Medication Score (RMS). ;Timepoint(s) of evaluation of this end point: Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint are the evaluation of the clinical benefit of Bromelain tablets hysan® by means of reduction of rhinosinusitis symptoms (nasal obstruction, nasal discharge, facial pain/pressure, reduction or loss of smell) during the treatment period, evaluation of the Peak Nasal Inspiratory Flow (PNIF), the evaluation of the Quality of life by the Sino-Nasal Outcome Test German Adapted Version Questionnaire (SNOT-20 GAV), nasal rhinoscopic inspection with optics (edema, secretion and redness), and cytokine analysis.;Timepoint(s) of evaluation of this end point: Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5 | — |
Countries
Germany
Contacts
Public ContactCoordinating Investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed