Recurrent respiratory tract infections MedDRA version: 14.1 Level: LLT Classification code 10038133 Term: Recurrent respiratory tract infections System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Broncho-Vaxom 11 mg/ml Oral solution
Product Name: Broncho-Vaxom® Drops
Product Code: not applicable
Pharmaceutical Form: Oral drops, solution
Other descriptive name: OM-85 concentrate
Con
Sponsors
OM PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy and safety of Broncho-Vaxom® drops compared to placebo in children in reducing the severity and the rate of respiratory tract infections;Secondary Objective: · Proportion of patients with recurrent respiratory tract infections (i.e. presenting 3 or more RTIs) up to the end of treatment period (V6). · Proportion of patients with at least one additional RTI up to the end of the study period (V7). · Proportion of patient suffering of gastro-intestinal infection during the treatment period. · Rate of gastro-intestinal infection during the treatment period · Severity of RTI symptoms with symptom score. · Duration of RTI. · Type and duration of concomitant treatment(s) with medication score · Proportion of patients suffering from viral (Influenza A and B, Respiratory Syncytial Virus (RSV)) or bacterial (ß-haemolytic Streptococcus A) infections detected with quick detection kits from nasal or throat swabs.;Primary end point(s): The primary objective of this study is to asses the efficacy and safety of Broncho-Vaxom drops compared to placebo in children in reducing the severity and the rate of respiratory tract infections;Timepoint(s) of evaluation of this end point: The end point will be evaluated after the last patient out | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variable is - the mean rate of RTI up to the end of the treatment period (V6), i.e. mean of the total number of RTIs per patient. -the proportion of patients with at least one additional RTI up to the end of the study period (V7) -the proportion of patients suffering from gastro-intestinal infection during the treatment period. -Rate of gastro-intestinal infection during the treatment period -the severity of RTI symptoms with symptom score -Duration of RTI -Type and duration of concomitant treatment(s)with medication score -proportion of patients suffering from viral or bacterial infections detected with quick detection kits from nasal or throat swabs ;Timepoint(s) of evaluation of this end point: The end point will be evaluated after the last patient out | — |
Countries
Belgium, Czech Republic, Hungary, Italy, Portugal
Contacts
Public ContactClinical Project Coordinator
OM PHARMA SA
Outcome results
None listed