Double-blind, placebo-controlled, randomized clinical study of Broncho Vaxom in children suffering from recurrent upper respiratory tract infections - BV -2005/01 PRIMES

OM PHARMA0 个研究点目标入组 420 人开始时间: 2007年12月17日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Out-patient of either sex; Patient aged between 2 years and 6 years (or in their 7th year); Patient known to his/her physician as suffering from recurrent URTIs (documented upper respiratory tract infections, minimum 4 episodes during the year preceding the study period); Patient suffering from an URTI at the enrolment visit; The beginning of this infection should not exceed 7 days prior to inclusion and has to occur after a steady period (without infection) of at least one week; Patient whose parent(s) or legal representative have given their written informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patient suffering from pneumonia or bronchiolitis at the enrolment visit;Patient with tonsillectomy and/or adenoidectomy if performed after the first upper RTI during the year preceding the study period; Patient with allergic asthma; Patient with mucoviscidosis; Patient with known significant systemic disease, i.e. hepatic and/or renal disease; Patient with malignant disease; Patient with auto-immune disease and other systemic diseases related to immune system disorders; Patient with diseases of the gastrointestinal tract which would impair absorption of the study medication; Patient with a known allergy or previous intolerance to the study medication.

发起方

OM PHARMA