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
- Conditions
- Recurrent upper respiratory tract infections in childrenMedDRA version: 9.1Level: LLTClassification code 10046306Term: Upper respiratory tract infection
- Registration Number
- EUCTR2006-002980-17-SK
- Lead Sponsor
- OM PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to confirm the efficacy and safety of <br>Broncho-Vaxom® compared to placebo in children suffering from recurrent upper respiratory tract infections.<br>;Secondary Objective: The secondary efficacy variables are:<br>- Proportion of patients with recurrent upper respiratory tract infections (i.e. presenting 3 or more URTIs) up to the end of treatment period (V6).<br>- Proportion of patients with at least one additional URTI up to the end of the study period (V7).<br>- Severity of URTI symptoms.<br>- Duration of URTI symptoms.<br>- Type and duration of concomitant treatment(s), e.g. antibiotics and expectorants.<br>- IgG2 level at baseline and at the end of treatment period (V6).<br>- Kiddy-Kindl® (4-7 years old) quality of life questionnaire (will not be completed for children 2-3 years old).;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.
- Secondary Outcome Measures
Name Time Method