E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent respiratory infections |
Infezioni respiratorie ricorrenti |
|
E.1.1.1 | Medical condition in easily understood language |
Respiratory infections |
Infezioni respiratorie |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062352 |
E.1.2 | Term | Respiratory tract infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To evaluate in pre-scholastic age children with recurrent respiratory infections the effects of the treatment with pidotimod and/or bifidobacteria on the prevention of respiratory infections. |
Valutare nei bambini con IRR in età prescolare gli effetti del trattamento con pidotimod e/o bifidobatteri sulla prevenzione delle infezioni respiratorie. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate both the duration and the intensity of respiratory infections, the QUolity of Life of parents, the tolerability and safety of the treatments. |
Valutare sia la durata che l’intensità delle IR, la Qualità di Vita dei genitori, la tollerabilità e sicurezza dei trattamenti. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children:
- both sex aged 3-6 years;
- integrated in scholastic ambient (nursery school, kindergarten);
- affected by recurrent respiratory infections defined as:
.. 6 or more episodes in the previous year: 01/10/2014 - 30/09/2015;
.. 1 or more episodes/month in the period september-april of the previous year: 01/09/2014 - 20/054/2015;
.. 3 or more lower respiratory tract infections in the previous year: 01/10/2014 - 30/09/2015;
- whose parents have given the appropriate consent to the study partecipation of their son. |
Bambini:
- di ambo i sessi di età compresa 3-6 anni;
- inseriti in ambiente scolastico (asilo nido, scuola materna);
- affetti da infezioni respiratorie ricorrenti (IRR) definite come:
.. 6 o più episodi nell'anno precedente: 01/10/2014 - 30/09/2015;
.. 1 o più episodi/mese nel periodo settembre-aprile dell'anno precedente: 01/09/2014 - 20/04/2015;
.. 3 o più infezioni delle vie aeree inferiori nell'anno precedente: 01/10/2014 - 30/09/2015;
- i cui genitori abbiano espresso validamente il loro consenso alla partecipazione allo studio del proprio figlio.
|
|
E.4 | Principal exclusion criteria |
- ongoing respiratory infection or other infections requiring hospitalization;
- story of bronchospasm;
- cardiopathies or severe systemic disease;
- chronic respiratory diseases (like cystic fibrosis and primary ciliary dyskinesia);
- immunodeficiencies;
- treatment in the last 4 weeks with probiotics, corticosteroids, immunostimulants or immunosuppressants;
- allergies or intolerance to pidotimod. |
- infezione respiratoria in atto o altre infezioni che richiedano ospedalizzazione;
- storia di broncospasmo;
- cardiopatie o patologie sistemiche gravi;
- patologie respiratorie croniche (come fibrosi cistica e discinesia ciliare primitiva);
- immunodeficienze;
- trattamento nelle 4 settimane precedenti con probiotici, corticosteroidi, immunostimolanti o immunosoppressori;
- allergie o intolleranze al pitotimod.
|
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of respiratory infections |
Numero di infezioni respiratorie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At sixth month |
Al sesto mese |
|
E.5.2 | Secondary end point(s) |
In relation to the respiratory infection episodes only:
- Duration of the episodes
- Days of treatment with antibiotic
- Nr. of visits to the Doctor
- Nr. of entries to the Emergency Room
- Nr. and duration of hospitalizations
- Nr. of days of absence from school
- Nr. of days of absence from work for parents
- Nr. of hours of baby sitting required
Questionnaire on Quality of Life of parents |
Relativamente ai soli episodi di IR:
- Durata degli episodi
- Giorni di trattamento con antibiotico
- N° di visite dal Medico
- N° di accessi al Pronto Soccorso
- N° e durata di ricoveri ospedalieri
- N° di giorni di assenza da scuola
- N° di giorni di assenza dal lavoro dei genitori
- N° di ore di Baby Sitter richieste
Questionario sulla Qualità della vita dei genitori |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |