Double-blind, placebo-controlled, randomised clinical study ofBroncho-Vaxom® in children suffering from recurrent upper respiratory tract infections - Broncho-Vaxom® in children with recurrent URTIs

OM PHARMA0 个研究点目标入组 420 人开始时间: 2007年7月18日最近更新: 2012年3月19日

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, according to one of the definitions under 7.1.1. of the protocol.
•- The beginning of this infection should not exceed 7 days prior to inclusion and has to occur after a steady period (without infections) 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
•- Patient treated with the following medications:
•-- antibiotics within one week before study start
•-- oral vaccination with live vaccine within 4 weeks before study start
•-- previous and/or concomitant immunosuppressive or immunostimulating therapy within 3 months before study start
•-- concomitant treatment with corticosteroids
•-- concomitant treatment with an investigational drug within 1 month before study start
•- Patient whose parents or legal representatives are unable to comply with the rules of this clinical study, especially if they do not accept intermediary phone calls (IPCs)
•- Participation in another clinical trial within 3 months prior to study start.

发起方

OM PHARMA