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

NCT00496574 | Unknown Phase 4 DMC

• 1 other identifier: RNN-102-06-KE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma

Keywords

asthma; immunotherapy; efficacy; children; symptoms score; quality of life; spirometry; PC20M

Outcome Measures

Primary Outcomes (1)

• clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function

  baseline (first visit), 12 months (second visit), 24 months (third visit), 36 months (fourth visit)

Secondary Outcomes (1)

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

  after 36 months (fourth visit)

Study Arms (2)

1

ACTIVE COMPARATOR

Biological: Novo Helisen Depot, Phostal

2

NO INTERVENTION

no intevention

Interventions

Novo Helisen Depot, Phostal BIOLOGICAL

subcutaneous immunotherapy

Also known as: Novo Helisen Depot

1

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

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

Lodz, 93-513, Poland

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Novo-Helisen Depot

Condition Hierarchy (Ancestors)

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

Study Officials

• Agnieszka Sobocińska, MD

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

  PRINCIPAL INVESTIGATOR

• Iwona Stelmach, MD PhD Prof

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

  STUDY CHAIR

Central Study Contacts

Agnieszka Sobocińska, MD

CONTACT

00 48 42 6895972; alergol@kopernik.lodz.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: May 1, 2006
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

PL (1)