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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 278

Inclusion Criteria

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

Exclusion Criteria

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:
? systemic 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 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)Subject with history of non-compliance with study medications or treatment protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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