Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01134757
First received: June 1, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

The present study is aimed to evaluate a bronchial allergen challenge with house dust mite and alternaria. Firstly, the years 2005, 2006, 2007, 2008 and 2009 will be retrospectively reviewed. Secondly, in 2010-2013, in the prospective part of the study the patients will undergo the bronchial allergen challenge to examine safety of the bronchial allergen challenge and change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy.


Condition Intervention
House Dust Mite Allergy
Bronchial Hyperresponsiveness
Biological: house dust mite and alternaria allergen bronchial challenge

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Retrospective and Prospective, Diagnostic, Open-label, Single-center Study of the Safety of the Bronchial Allergen Challenge With House Dust Mite, Grass Pollen and Alternaria and Predictors for Positive Reaction.

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Safety of bronchial allergen challenge with house dust mite and alternaria. [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
    Early Allergic Reaction (EAR) and Late Allergic Reaction (LAR) will be monitored.


Secondary Outcome Measures:
  • Correlation of predictors like skin prick testing, specific IgE, total IgE, allergen specific dose to PD20 FEV1, nonspecific hyperresponsiveness to methacholine and exhaled NO. [ Time Frame: two weeks ] [ Designated as safety issue: No ]
  • Development of allergen specific bronchial hyperreactivity before and after SIT [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
house dust mite and alternaria allergy
Patients with house dust mite or alternaria allergy will undergo a bronchial allergen challenge with mite or alternaria extract. The early asthmatic response (EAR) and the late asthmatic response (LAR) will be measured before and after one year of allergen specific immunotherapy. Except of the challenge no interventions are planned.
Biological: house dust mite and alternaria allergen bronchial challenge
2 ml of saline-dissolved lyophylised house dust mite or alternaria in concentration 5000 standard biological units (SBU/ml) dosed in 6 steps of 5, 10, 20, 40, 80, and 160 SBU. 10 minutes after each step up a spirometry will be performed the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given.
Other Name: Lyophylised allergen (Allergopharma, Rheinbeck, Germany)

Detailed Description:

Specific bronchial allergen challenge is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. However, in preschool age there is only a few data about specific bronchial allergen challenges. Douglas (1) evaluated the predictors of positive response to bronchial allergic challenges with house dust mite and grass pollen in twelve 5-to 6-year-old atopic children. The most statistically significant predictors were the extent of atopy proven by skin prick testing, specific IgE, symptoms of asthma, and persistent atopic eczema. However, the number of patients was small. Therefore, more research is needed to confirm these findings. Further, the nonspecific bronchial hyperreactivity was found to have a high positive predictive value for positive reactions (2). To our best knowledge, this aspect is not investigated in children.

This study examines retro- and prospectively the safety of a bronchial allergic challenge with house dust mite, grass pollen and alternaria. The retrospective part will evaluate the associations of early allergic reaction, skin prick testing, specific IgE, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. The prospective part will measure the early allergic reaction (EAR) and focus on the late allergic reaction (LAR)and examine the change of allergen specific bronchial hyperreactivity before and after allergen specific immunotherapy. The study consists of two visits in the first year of the study and one follow-up visit per year. At first visit, all the patients undergo skin prick testing, measurement of exhaled NO, spirometry/IOS and bronchial methacholine challenge. At next visit specific bronchial allergen challenge will be performed and a blood sample will be taken. After that, each patient will measure hourly the peak flow during the next 10-hours. This procedure will be repeated after the first and second year of allergen specific immunotherapy. The safety issue of the study will be published separately. The change of the allergen specific bronchial hyperreactivity will be evaluated after every year of the study.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Age between 5 and 18 years
  • Known house dust mite or alternaria allergy

Exclusion Criteria:

  • Age < 5 years and > 18 years
  • Lung function VC < 80 % and FEV1 < 75 %
  • Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
  • Pregnancy
  • Treatment with systemic corticosteroids
  • Documented alcohol, substance, and/or drug abuse
  • Incapability to perform all study procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134757

Contacts
Contact: Johannes Schulze, Dr. 0049- 69- 6301- 5381 johannes.schulze@kgu.de
Contact: stefan Zielen, Prof.Dr. 0049- 69- 6301- 83063 stefan.zielen@kgu.de

Locations
Germany
Goethe University, Recruiting
Frankfurt am Main, Germany, 60590
Contact: Johannes Schulze, Dr.    0049- 69- 6301- 5381    johannes.schulze@kgu.de   
Sub-Investigator: Stefan Zielen, Prof. Dr.         
Sub-Investigator: Markus Rose, PD Dr.         
Sub-Investigator: Martin Rosewich, Dr.         
Sub-Investigator: Olaf Eickmeier, Dr.         
Principal Investigator: Johannes Schulze, Dr.         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Johannes Schulze, Dr. Goethe University, Frankfurt, Germany
  More Information

Publications:
Responsible Party: Johannes Schulze MD, Consultant department of allergy, pulmonology, and cystic fibrosis, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01134757     History of Changes
Other Study ID Numbers: KGU-17/10
Study First Received: June 1, 2010
Last Updated: November 8, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
EAR
LAR
BHR
house dust mite
alternaria

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014