E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Respiratory Tract Infections |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent Respiratory Tract Infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067473 |
E.1.2 | Term | Immunomodulatory therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 confirm efficacy of IMUNOR® in treatment of recurrent respiratory tract infections in pediatric population. |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety of the IMUNOR® treatment in pediatric subjects. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female pediatric subjects aged 3-10 years, inclusive;
2. Parents or a legal guardian of the subject willing to sign and date a written informed consent for participation of their child in the study. For children aged ≥ 7 years of age, being able to understand the provided information, an informed assent shall be also obtained;
3. Subjects with confirmed or suspected secondary immunodeficiency with properly documented recurrent RTIs of the upper and/or lower respiratory tract, or acute otitis media episodes,with ≥ 5 episodes during the last October to September period, among them ≥ 3 episodes in the period from October to March;
4. Parents or a legal guardian able to cooperate and come for the required site visits.
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E.4 | Principal exclusion criteria |
1. Subjects with known hypersensitivity to any ingredient of the study medication;
2. Subjects with a congenital immunity disorder confirmed by a laboratory and/or genetic examination;
3. Subjects with documented anatomical respiratory tract anomalies;
4. Subjects with documented presence of focuses or airway obstruction (adenoids, Grade IV tonsillar hypertrophy and/or chronic tonsillitis, foreign body or nasal polyps);
5. Subjects with documented chronic middle ear inflammation, cholesteatoma, chronic ear drum perforation or inserted vent tube;
6. Subjects with known history of gastro-oesophageal reflux and/or aspiration syndromes;
7. Subjects who have undergone procedures like adenoidectomy, tonsillectomy, middle ear surgery or inflamed carious tooth extraction over the last 6 months or are planned to undergo such procedure during the course of the study;
8. Subjects using any immune modulating treatment (transfer factor, bacterial lysates, proteolytic enzymes, gamma-globulins, etc.) over the last 18 months or planned to receive such treatment during the course of the study;
9. Subjects in the initial stages of allergenic immunotherapy;
10. Subjects with planned vaccination scheduled for the 3 months study treatment period;
11. Subjects with anemia corrected by transfusion(s) or supplemental iron preparations over the last 6 months;
12. Subjects receiving a long term (>4 weeks) penicillin prophylaxis for chronic streptococcal infection e.g. chronic tonsillitis;
13. Participation in a clinical study within 30 days prior the screening visit;
14. Subjects with any clinically significant condition or illness, which, in the opinion of the Investigator, would affect safety of the subject or clinical evaluation of the study;
15. Subjects with a known history of tuberculosis.
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of documented respiratory tract infections during 3 months of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
All episodes starting during the Treatment Phase and being resolved during the Follow-up Phase will be included into the analysis. Respiratory tract infections, including acute otitis media episodes, starting prior commencement of study medication intake will be documented, but not used for evaluation.
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E.5.2 | Secondary end point(s) |
- The number of subjects without reported respiratory tract infections
- Duration of RTI episodes
- Use of antibiotics
- Laboratory assessments - Immunology (IgG, IgM, IgA, CD3, CD4, CD8); Hematology (hemoglobin, hematocrit, total and differential leukocyte count, red blood cell count, platelet count); Serum chemistry (glucose, total proteins, serum albumin, urea, serum creatinine, AST, ALT, total bilirubin, direct bilirubin, sodium, potassium, CRP); Urine analysis (pH, specific gravity, proteins, glucose, ketone bodies, bilirubin, blood, nitrite, urobilinogen and a microscopic examination)
- Adverse events
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Since the signed ICF till the end of Follow-up phase |
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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 | No |
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 | Yes |
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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 30 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 30 |