Chronic rhinosinusitis MedDRA version: 14.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients of either sex aged 18 - 75 - patients must experience a facial pain especially unilaterally; and at least one of the two following symptoms (> 50 % of days in the last 3 months): more than 12 consecutive weeks of symptomatic nasal obstruction and/or more than 12 weeks of symptomatic nasal discharge - an otorhinolaryngologist (ENT) evaluation and diagnosis of chronic inflammatory rhinosinusitis (hyperplastic mucosa, nasal polyps) and either endoscopic signs and/or CT -patients having given their written 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - sinus surgery within the last 3 months - acute illness within the last 2 weeks requiring antibiotics - immunosuppression - sinister signs requiring intermediate intervention - serious concomitant disease, which might interfere with or modify the outcome - patients with acute bacterial rhinosinusitis as increase of symptoms after 5 days or persistent symptoms after 10 days with less than 12 weeks duration - patients under immunosuppressive or immunostimulating therapy within 1 month prior to study start - patients under systemic corticosteroid therapy within 1 month prior to study start with a regular oral corticosteroids > 10 mg of prednisolone more than 2 weeks - patients with a known allergy or previous intolerance or known hypersensitivity to the trial drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of Broncho-Vaxom in adults suffering from chronic rhinosinusitis.;Secondary Objective: To evaluate the efficacy and safety of Broncho-Vaxom concerning the time until patient is "asymptomatic" and consumption of rescue medication (antibiotics, analgetics and topical corticosteroids) in comparison to Placebo.;Primary end point(s): Comparisons between the two groups of severity of rhinosinusitis (SNOT-20) during the trial (AUC).;Timepoint(s) of evaluation of this end point: SNOT-20 should be filled in at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Survival : Time until only one symptom is mild or no symptoms are reported - Rescue medication - Antibiotic medication - Global assessment of efficacy by patient and investigator;Timepoint(s) of evaluation of this end point: Survival, rescue and antibiotic medication: at each visit Global assessment: at the last visit | — |
Countries
Austria, Germany, Switzerland
Contacts
Public ContactAude Chevalier
OM Pharma SA
Outcome results
None listed