Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

Medical University of Lodz60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Novo Helisen Depot, PhostalBIOLOGICAL

subcutaneous immunotherapy

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, Poland

RECRUITING

Outcomes

Primary Outcomes

clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function

Time frame: baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)

Secondary Outcomes

bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma.

Time frame: after 36 months (fourth visit)

Central Contacts

Agnieszka Sobocińska, MD

CONTACT

00 48 42 6895972 alergol@kopernik.lodz.pl

Data from ClinicalTrials.gov

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