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Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

This study is currently recruiting participants.
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00496561
First received: July 3, 2007
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  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, 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.


Condition Intervention Phase
Asthma
 Biological: subcutaneous immunotherapy (House Dust Mites)
Other: placebo of subcutaneous immunotherapy (House Dust Mites)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Early Clinical and Immunological Efficacy of Specific Immunotherapy to Dust Mites in Children With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • clinical symptoms, reliever drugs usage, controller medication usage, quality of life, lung function, chosen markers of inflammation (ECP, specific IgE, specific IgG) induction of regulatory lymphocytes (Treg) - Foxp3 mRNA expression [ Time Frame: baseline (first visit), after 3 months (second visit), 12 months (third visit), 24 months (fourth visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT (skin prick tests) [ Time Frame: after 24 months from first visit (fourth visit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 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
subcutaneous immunotherapy (House Dust Mites)
 Biological: subcutaneous immunotherapy (House Dust Mites)
subcutaneous immunotherapy (House Dust Mites)
Placebo Comparator: 2
placebo of subcutaneous immunotherapy (House Dust Mites)
 Other: placebo of subcutaneous immunotherapy (House Dust Mites)
placebo of subcutaneous immunotherapy (House Dust Mites)
Other Name: placebo of subcutaneous immunotherapy (House Dust Mites)

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496561

Contacts
Contact: Dorota Jurałowicz, MD 00 48 42 6895972 alergol@kopernik.lodz.pl

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

No publications provided

Responsible Party: Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT00496561     History of Changes
Other Study ID Numbers: RNN-149-06-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
children
regulatory T cells
ECP
 PC20M
Quality of Life
Symptoms score
Spirometry

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 May 16, 2013