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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00496574
• Other study ID #: RNN-102-06-KE
• Status: Recruiting
• Phase: Phase 4
• First received: July 3, 2007
• Last updated: February 6, 2013
• Start date: May 2006
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Medical Universtity of Lodz
• Contact: Agnieszka Sobocinska, MD
• Phone: 00 48 42 6895972
• Email: alergol[@]kopernik.lodz.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Novo Helisen Depot, Phostal
subcutaneous immunotherapy

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	bronchial hyperreactivity with methacholine, and presence and type of allergy after tree years of SIT in children with asthma.		after 36 months (fourth visit)	No