Double-blind, placebo-controlled, randomised clinical study of Broncho-Vaxom® drops in children suffering from recurrent Respiratory Tract Infections (RTIs) - Broncho-Vaxom® drops in children with recurrent RTIs

OM PHARMA SA0 个研究点目标入组 278 人开始时间: 2010年7月1日最近更新: 2013年1月14日

适应症

试验速览

暂无简介。

•1) Out-patient of either gender
•2) Patient aged between 12 months and 6 years (or in their 7th year)
•3) Patient known to his/her physician as suffering from recurrent RTI (documented respiratory tract infections, minimum 4 episodes during the year preceding the study period)
•4) Patient suffering from a RTI at the enrolment visit, according to one of the definitions under 2.2 (except rhinosinusitis, which does not respect the inclusion criterion 5).
•5) 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
•6) 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: 278
•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

•1) Patient with tonsillectomy and/or adenoidectomy if performed after the first RTI during the year preceding the study period
•2) Patient with allergic asthma
•3) Patient with mucoviscidosis
•4) Patient with known significant systemic disease, i.e. hepatic and/or renal disease
•5) Patient with malignant disease
•6) Patient with auto-immune disease and other systemic diseases related to immune system disorders
•7) Patient with diseases of the gastro-intestinal tract which would impair absorption of the study medication
•8) Patient with a known allergy or previous intolerance to the study medication
•9) Patient treated with the following medications:
•? 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 systemic corticosteroids for more than 10 consecutive days
•? concomitant treatment with any other investigational drug within 1 month before study start
•10) 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)
•11) Participation in another clinical trial within 1 month prior to study start.
•12) Patient with history of non-compliance with study medications.

发起方