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

NCT ID: NCT00496574

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Novo Helisen Depot, Phostal

Intervention Type BIOLOGICAL

subcutaneous immunotherapy

2

no intevention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Novo Helisen Depot, Phostal

subcutaneous immunotherapy

Intervention Type BIOLOGICAL

Other Intervention Names

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Novo Helisen Depot

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Iwona Stelmach

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Agnieszka Sobocińska, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland

Iwona Stelmach, MD PhD Prof

Role: STUDY_CHAIR

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland

Locations

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Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Agnieszka Sobocińska, MD

Role: CONTACT

00 48 42 6895972

Facility Contacts

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Agnieszka Sobocińska, MD

Role: primary

00 48 42 6895972

Other Identifiers

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RNN-102-06-KE

Identifier Type: -

Identifier Source: org_study_id

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