Clinical phase IV study assessing the efficacy and safety of the medicinal product Groprinosin in treatment of recurrent airway inflammation in children with impaired cellular immunity and diagnosed or undiagnosed allergic disease

Phase 1

Conditions: Recurrent airway inflammation in children with impaired cellular immunity.
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-003303-18-PL

Lead Sponsor: Gedeon Richter Polska Sp. z o. o.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1 Age> 24 months to <12 years at inclusion in the study.
2 Consent of parent / legal representative of the child to participate in the study, confirmed by signing the Informed Consent Form for Parent / legal representative of the patient before the first study procedures and after obtaining explanations concerning the design and purpose of the study;
3 Frequent respiratory infection (not less than 6 cases per year), of chronic (> 10 days), difficult to treat (the slow process of recovery).
4 Patients with laboratory-confirmed impaired cellular immunity (reduction in absolute number and / or interest of T cells and / or impairment of the function) with a possible simultaneous slight decrease in the level of fractions of IgG, IgM, IgA.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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

1 Renal failure , determined on the basis of clinical evaluation and laboratory tests .
2 Gout , kidney stones and increased uric acid in the blood indicated on the basis of medical history and laboratory tests .
3 Hypersensitivity to the active substance or any Groprinosin drug excipients .
4 Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase - isomaltase insufficiency.
5 Administration of xanthine oxidase inhibitors , diuretics or azidothymidine .
6 Currently recognized infectious or contagious disease or inflammation of different etiologies and the need for antibiotic treatment.
7 The use of immunostimulatory drugs (including nonspecific vaccines ) or immunosuppressants within 6 months or corticosteroids- systemic, inhaled and used externally within 1 month prior to inclusion in the study.
8 The use of specific immunotherapy and vaccinations within 4 weeks prior to enrollment .
9 The use of antibiotic therapy within 1 month prior to inclusion in the study.
10 Another reason , which in the opinion of the investigator disqualify a patient from the study