Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

Phase 4

• Conditions: Asthma
• Interventions: Biological: subcutaneous immunotherapy (House Dust Mites); Other: placebo of subcutaneous immunotherapy (House Dust Mites)

• Registration Number: NCT00496561
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	subcutaneous immunotherapy (House Dust Mites)	subcutaneous immunotherapy (House Dust Mites)
2	placebo of subcutaneous immunotherapy (House Dust Mites)	placebo of subcutaneous immunotherapy (House Dust Mites)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz; 🇵🇱 Lodz, Poland