E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent upper respiratory tract infections in children |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046306 |
E.1.2 | Term | Upper respiratory tract infection |
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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 confirm the efficacy and safety of Broncho-Vaxom® compared to placebo in children suffering from recurrent upper respiratory tract infections.
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
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, 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
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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 - 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 any other 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.
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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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Information not present in EudraCT |
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) | 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
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 |
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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
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |