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

February 6, 2013 updated by: Iwona Stelmach, Medical University of Lodz

Evaluation of Long-term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial 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, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Locations

  • Poland
      • Lodz, Poland, 93-513
        • Recruiting
        • Department of Pediatrics and Allergy, Medical University of Lodz, Poland
        • Contact:
        • Principal Investigator:
          • Iwona Stelmach, MD PhD Prof
        • Sub-Investigator:
          • Agnieszka Sobocińska, 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 16 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Biological: Novo Helisen Depot, Phostal
subcutaneous immunotherapy
Other Names:
  • Novo Helisen Depot
No Intervention: 2
no intevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
after 36 months (fourth visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University 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

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

May 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-102-06-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.

Clinical Trials on Asthma

Clinical Trials on Novo Helisen Depot, Phostal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe