Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial 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, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

Detailed Description
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According to Global Initiative for Asthma treatment of asthma is based on avoidance of allergens, pharmacological treatment, and specific immunotherapy. 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, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

Official Title
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Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: Novo Helisen Depot, Phostal


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: 8 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: Novo Helisen Depot, Phostal<br>* subcutaneous immunotherapy<br>* Other names: Novo Helisen Depot;|
| No Intervention: 2<br>no intevention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function |  | baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma. |  | after 36 months (fourth visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, immunotherapy, efficacy, children, symptoms score, quality of life, spirometry, PC20M