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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00496574
First received: July 3, 2007
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Biological: Novo Helisen Depot, Phostal
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Novo Helisen Depot, Phostal
subcutaneous immunotherapy
Other Name: Novo Helisen Depot
No Intervention: 2
no intevention

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496574

Contacts
Contact: Agnieszka Sobocińska, MD 00 48 42 6895972 alergol@kopernik.lodz.pl

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland Recruiting
Lodz, Poland, 93-513
Contact: Agnieszka Sobocińska, MD    00 48 42 6895972    alergol@kopernik.lodz.pl   
Principal Investigator: Iwona Stelmach, MD PhD Prof         
Sub-Investigator: Agnieszka Sobocińska, MD         
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Agnieszka Sobocińska, MD Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
Study Chair: Iwona Stelmach, MD PhD Prof Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
  More Information

No publications provided

Responsible Party: Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT00496574     History of Changes
Other Study ID Numbers: RNN-102-06-KE
Study First Received: July 3, 2007
Last Updated: February 6, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
asthma
immunotherapy
efficacy
children
symptoms score
quality of life
spirometry
PC20M

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014