Recurrent airway inflammation in children with impaired cellular immunity.
Conditions
Interventions
Trade Name: Groprinosin 50 mg/ml, syrup
Pharmaceutical Form: Syrup
INN or Proposed INN: INOSINE ACEDOBEN DIMEPRANOL
CAS Number: 36703-88-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
Gedeon Richter Polska Sp. z o. o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Age> 24 months to 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of short-and long-term safety and efficacy of the medicinal product Groprinosin 50 mg / ml syrup in the treatment of recurrent airway inflammation in children with impaired cellular immunity and diagnosed or undiagnosed allergic disease.;Secondary Objective: Not applicable;Primary end point(s): Evaluation of the short-term efficacy : • Number of episodes of respiratory infection- comparison of period 4 months before and 4 months after the start of the treatment period 1 • The average duration of episodes of respiratory tract infection - (number of sickness days ) comparison of period 4 months before and 4 months after the start of the treatment period 1 • Change in the severity of the infection, according to the scale of clinical symptoms - a comparison of the period 4 months before and 4 months after the start of the treatment period 1 Evaluation of the long-term efficacy : • The number of episodes of respiratory tract infection - comparison of period 12 months before and 12 months of treatment period and follow-up ( number of infectious episodes per year ) . • The average duration of episodes of respiratory tract infection (number of sickness days ) comparison of the 12- month duration of the study and observation to the pre-treatment period (12 months). • Changing the severity of infection by clinical symptoms - comparison of period of 12 months pre-treatment to the period of 12 months of treatment and follow-up • The number of antibiotic treatment- comparison of period of 12 months before treatment and 12 months of treatment and follow-up;Timepoint(s) of evaluation of this end point: after the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in the results of cytometry of peripheral blood lymphocytes (CD3, CD4, CD8, CD19, CD16CD56, CD3/HLA-DR, CD45) obtained after 4 months of the study and observation in relation to the results obtained at the time of enrollment. - Change the results of blastic transformation of lymphocytes in cultures stimulated with PHA, after 4 months of the study comparing the results obtained at the time of enrollment. - Change in concentrations of IgG, IgA, IgM in serum, after 4 months of the study and observation in comparison to the results of these studies obtained at the time of enrollment. - Change in the concentration of Th1 cytokine profile, and Th17 and Th 2 (IL-2, IFN-gamma, TNF-alpha, IL-4, IL-6, IL-10 and IL-17) after 4 months of the study and follow-up in comparison to the results of these tests obtained at the time of enrollment.;Timepoint(s) of evaluation of this end point: after the end of the study | — |
Countries
Poland
Contacts
Public ContactDzial Medyczny (Medical Department)
Dr n. med. Pawel Rakowski
Outcome results
None listed