E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent respiratory tract infections |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038133 |
E.1.2 | Term | Recurrent respiratory tract infections |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
· 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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is defined as last visit of the last patient followed by data base lock. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |