Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma - Full Text View

Sponsored by:	Medical Universtity of Lodz
Information provided by:	Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00496574

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, bronchial hyperreactivity with methacholine, and presence and type of allergy after three years of SIT in children with asthma.

Condition	Intervention	Phase
Asthma	Other: no intervention Biological: Novo Helisen Depot, Phostal	Phase IV

MedlinePlus related topics: Allergy Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of Long-Term Clinical Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: Novo Helisen Depot, Phostal subcutaneous immunotherapy
2: No Intervention no intervention	Other: no intervention no intervention, only pharmacological asthma treatment (no immunotherapy)

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.

Eligibility

Ages Eligible for Study:	8 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: NCT00496574

Locations

Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Poland, 93-513

Sponsors and Collaborators

Medical Universtity 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

More Information

No publications provided

Responsible Party:	Department of Pediatrics and Allergy, Medical University of Lodz, Poland ( Agnieszka Sobocińska, MD )
Study ID Numbers:	RNN-102-06-KE
Study First Received:	July 3, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00496574 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:

asthma
immunotherapy
efficacy
children

symptoms score
quality of life
spirometry
PC20M

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases

Hypersensitivity, Immediate
Quality of Life
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 07, 2009