Recurrent upper respiratory tract infections in children MedDRA version: 9.1 Level: LLT Classification code 10046306 Term: Upper respiratory tract infection
Conditions
Interventions
Trade Name: Broncho-Vaxom®
Product Name: Broncho-Vaxom®
Product Code: R07AX
Pharmaceutical Form: Capsule*
Other descriptive name: lyophilised bacterial lysate
Concentration unit: mg milligram(s)
Conce
Sponsors
OM PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
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, 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
Exclusion criteria
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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to confirm the efficacy and safety of Broncho-Vaxom® compared to placebo in children suffering from recurrent upper respiratory tract infections. ;Secondary Objective: The secondary efficacy variables are: - 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 symptoms. - Type and duration of concomitant treatment(s), e.g. antibiotics and expectorants. - IgG2 level at baseline and at the end of treatment period (V6). - 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. | — |
Countries
Austria, Belgium, Czech Republic, Hungary, Italy
Outcome results
None listed