Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

Medical University of Lodz

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Other: placebo of subcutaneous immunotherapy (House Dust Mites); Biological: subcutaneous immunotherapy (House Dust Mites)

Study type: Interventional

Funder types: Other

Identifiers

NCT00496561

RNN-149-06-KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

subcutaneous immunotherapy (House Dust Mites)

Treatment:

Biological: subcutaneous immunotherapy (House Dust Mites)

2

Placebo Comparator group

Description:

placebo of subcutaneous immunotherapy (House Dust Mites)

Treatment:

Other: placebo of subcutaneous immunotherapy (House Dust Mites)