Asthma
Conditions
Keywords
asthma, immunotherapy, children, regulatory T cells, ECP, PC20M, Quality of Life, Symptoms score, Spirometry
Brief summary
The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
Detailed description
Specific immunotherapy is the only one causal treatment method of atopic diseases including bronchial asthma in children. The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms,reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.
Interventions
BIOLOGICALsubcutaneous immunotherapy (House Dust Mites)
subcutaneous immunotherapy (House Dust Mites)
OTHERplacebo of subcutaneous immunotherapy (House Dust Mites)
placebo of subcutaneous immunotherapy (House Dust Mites)
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* patients allergic to house dust mites * patients with moderate bronchial asthma * patients with controlled asthma * patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group) * patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)
Exclusion criteria
* patients allergic for other perennial and seasonal allergens * patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator * medications that resulted in patient exclusion included:anti-parasites or oral corticosteroids within 6 months before the first visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical symptoms, reliever drugs usage, controller medication usage, quality of life, lung function, chosen markers of inflammation (ECP, specific IgE, specific IgG) induction of regulatory lymphocytes (Treg) - Foxp3 mRNA expression | baseline (first visit), after 3 months (second visit), 12 months (third visit), 24 months (fourth visit) |
Secondary
| Measure | Time frame |
|---|---|
| bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT (skin prick tests) | after 24 months from first visit (fourth visit) |
Countries
Poland
Contacts
Primary ContactDorota Jurałowicz, MD
Outcome results
None listed