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

• Conditions: RECURRENT UPPER RESPIRATORY TRACT INFECTIONS; MedDRA version: 6.1Level: PTClassification code 10047482

• Registration Number: EUCTR2006-002980-17-IT
• Lead Sponsor: OM PHARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the efficacy and safety of BRONCHO-VAXOM compared to placebo in children suffering from recurrent upper respiratory tract infections (URTI).;Secondary Objective: Proportion of patients with recurrent upper respiratory tract infections (i.e. presenting 3 or more URTIs) up to the end of treatment period (V6); Proportion of patients with at least one additional URTI up to the end of the study period (V7); Severity of URTI symptoms; Duration of URTI.;Primary end point(s): The primary efficacy variable is the mean rate of URTIs up to the end of the treatment period (V6), i.e. mean of the total number of URTIs per patient.