Effect of Specific Immunotherapy to Dust Mites in Children With Asthma
February 6, 2013 updated by: Iwona Stelmach, Medical University of Lodz
Evaluation of Early Clinical and Immunological Efficacy of Specific Immunotherapy to Dust Mites in Children With Asthma
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lodz, Poland, 93-513
- Recruiting
- Department of Pediatrics and Allergy, Medical University of Lodz
-
Principal Investigator:
- Iwona Stelmach, MD, PhD, Prof
-
Contact:
- Dorota Jurałowicz, MD
- Phone Number: 00 48 42 6895972
- Email: alergol@kopernik.lodz.pl
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Sub-Investigator:
- Dorota Jurałowicz, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
subcutaneous immunotherapy (House Dust Mites)
|
subcutaneous immunotherapy (House Dust Mites)
|
|
Placebo Comparator: 2
placebo of subcutaneous immunotherapy (House Dust Mites)
|
placebo of subcutaneous immunotherapy (House Dust Mites)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
baseline (first visit), after 3 months (second visit), 12 months (third visit), 24 months (fourth visit)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
after 24 months from first visit (fourth visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Anticipated)
November 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
July 3, 2007
First Submitted That Met QC Criteria
July 3, 2007
First Posted (Estimate)
July 4, 2007
Study Record Updates
Last Update Posted (Estimate)
February 7, 2013
Last Update Submitted That Met QC Criteria
February 6, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNN-149-06-KE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.