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Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496561
First Posted: July 4, 2007
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Iwona Stelmach, 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) ]

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) ]

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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 3, 2007
First Posted: July 4, 2007
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Iwona Stelmach, 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