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Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
subcutaneous immunotherapy (House Dust Mites)
placebo of subcutaneous immunotherapy (House Dust Mites)
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, immunotherapy, children, regulatory T cells, ECP, PC20M, Quality of Life, Symptoms score, Spirometry

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Pediatrics and Allergy, Medical University of LodzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

subcutaneous immunotherapy (House Dust Mites)

placebo of subcutaneous immunotherapy (House Dust Mites)

Outcomes

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

Secondary Outcome Measures

bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT (skin prick tests)

Full Information

First Posted
July 3, 2007
Last Updated
February 6, 2013
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT00496561
Brief Title
Effect of Specific Immunotherapy to Dust Mites in Children With Asthma
Official Title
Evaluation of Early Clinical and Immunological Efficacy of Specific Immunotherapy to Dust Mites in Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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, 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, immunotherapy, children, regulatory T cells, ECP, PC20M, Quality of Life, Symptoms score, Spirometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
subcutaneous immunotherapy (House Dust Mites)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo of subcutaneous immunotherapy (House Dust Mites)
Intervention Type
Biological
Intervention Name(s)
subcutaneous immunotherapy (House Dust Mites)
Intervention Description
subcutaneous immunotherapy (House Dust Mites)
Intervention Type
Other
Intervention Name(s)
placebo of subcutaneous immunotherapy (House Dust Mites)
Intervention Description
placebo of subcutaneous immunotherapy (House Dust Mites)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorota Jurałowicz, MD
Phone
00 48 42 6895972
Email
alergol@kopernik.lodz.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD, PhD, Prof
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dorota Jurałowicz, MD
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics and Allergy, Medical University of Lodz
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorota Jurałowicz, MD
Phone
00 48 42 6895972
Email
alergol@kopernik.lodz.pl
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD, PhD, Prof
First Name & Middle Initial & Last Name & Degree
Dorota Jurałowicz, MD

12. IPD Sharing Statement

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Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

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