E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
RECURRENT UPPER RESPIRATORY TRACT INFECTIONS |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047482 |
|
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 |
To confirm the efficacy and safety of BRONCHO-VAXOM compared to placebo in children suffering from recurrent upper respiratory tract infections (URTI). |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
|
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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |