Multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of Broncho-Vaxom in adults suffering from chronic rhinosinusitis - Broncho-Vaxom in adults suffering from chronic rhinosinusitis

OM Pharma SA0 个研究点目标入组 200 人开始时间: 2008年2月15日最近更新: 2012年5月8日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方