A study which aims at evaluating the efficacy and tolerability of bromelain tablets hysan® in patients suffering from chronic rhinosinusitis.
- Conditions
- Patients suffering from chronic rhinosinusitisTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-003896-37-DE
- Lead Sponsor
- RSAPHARM Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method