E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
respiratory infections in children. |
|
E.1.1.1 | Medical condition in easily understood language |
respiratory infections in children. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
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 the efficacy of Pidotimod in reducing the rate of respiratory infections in healthy children. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the duration of respiratory infections
To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs)
To report the adverse effects of Pidotimod
To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children
To evaluate the drug compliance |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy children between 3- 4 years old
Caucasian race
Children who had never attended the kindergarten
Signed informed consent obtained from parents or legal guardian |
|
E.4 | Principal exclusion criteria |
Being affected of a condition predisposing to recurrent respiratory infections such as immunological, neurological, renal, cardiovascular, hematological and neoplastic diseases, bronchodysplasia, Down syndrome and cystic fibrosis
Congenital anatomical abnormalities of the respiratory tract
Passive smoke exposure
Having at least one brother or sister attending the kindergarten
Known intolerance or allergy to Pidotimod
Assumption of an immunostimulant prior to study inclusion |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of Pidotimod in reducing the rate of respiratory infections in healthy children. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the study (7 months) |
|
E.5.2 | Secondary end point(s) |
To evaluate the duration of respiratory infections
To evaluate concomitant medications used during the study period (eg: antibiotics, systemic corticosteroids, antipyretics, antihistamines,mucolytics, antitussive and expectorant drugs)
To report the adverse effects of Pidotimod
To evaluate the number of episodes of caregiver absenteeism from work and lost school days in children
To evaluate the drug compliance |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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
|
|
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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |