Clinical trial NCT00496574: Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma
Official title: Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
immunotherapy
efficacy
children
symptoms score
quality of life
spirometry
PC20M
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function
timeFrame: baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)
Secondary outcomes:
measure: bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma.
timeFrame: after 36 months (fourth visit)
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
name: Agnieszka Sobocińska, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
name: Iwona Stelmach, MD PhD Prof
role: STUDY_CHAIR
References: