Recurrent Respiratory Tract Infections MedDRA version: 16.0 Level: PT Classification code 10067473 Term: Immunomodulatory therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: IMUNOR
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: Transferendi factor suillus
CAS Number: 8000043-00-7
Other descriptive name: TRANSFER FACTOR
Concentration unit: mg milli
Sponsors
ImunomedicA, a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 210 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm efficacy of IMUNOR® in treatment of recurrent respiratory tract infections in pediatric population.;Secondary Objective: To evaluate safety of the IMUNOR® treatment in pediatric subjects. ;Primary end point(s): The number of documented respiratory tract infections during 3 months of treatment. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: Since the signed ICF till the end of Follow-up phase | — |
Countries
Slovakia
Contacts
Public ContactManaging director
ImunomedicA, a.s.
Outcome results
None listed