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

• Conditions: Recurrent respiratory tract infections; MedDRA version: 12.0Level: LLTClassification code 10038133Term: Recurrent respiratory tract infections

• Registration Number: EUCTR2009-013378-42-HU
• Lead Sponsor: OM PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-11
• Last Update Posted: 3 September 2012

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:
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:
? 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified