Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Early Clinical and Immunological Efficacy of Specific Immunotherapy to Dust Mites in Children With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: subcutaneous immunotherapy (House Dust Mites)
* Other: placebo of subcutaneous immunotherapy (House Dust Mites)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>subcutaneous immunotherapy (House Dust Mites) | Biological: subcutaneous immunotherapy (House Dust Mites)<br>* subcutaneous immunotherapy (House Dust Mites)<br>|
| Placebo Comparator: 2<br>placebo of subcutaneous immunotherapy (House Dust Mites) | Other: placebo of subcutaneous immunotherapy (House Dust Mites)<br>* placebo of subcutaneous immunotherapy (House Dust Mites)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, immunotherapy, children, regulatory T cells, ECP, PC20M, Quality of Life, Symptoms score, Spirometry