Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.

NCT01134757 | Completed

• 1 other identifier: KGU-17/10
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

House Dust Mite Allergy; Bronchial Hyperresponsiveness

Keywords

EAR; LAR; BHR; house dust mite; alternaria

Outcome Measures

Primary Outcomes (1)

• Safety of bronchial allergen challenge with house dust mite and alternaria.

  Early Allergic Reaction (EAR) and Late Allergic Reaction (LAR) will be monitored.

  10 hours

Secondary Outcomes (2)

• Correlation of predictors like skin prick testing, specific IgE, total IgE, allergen specific dose to PD20 FEV1, nonspecific hyperresponsiveness to methacholine and exhaled NO.

  two weeks

• Development of allergen specific bronchial hyperreactivity before and after SIT

  two weeks

Study Arms (1)

house dust mite and alternaria allergy

OTHER

As the intervention 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 further interventions are planned.

Biological: house dust mite and alternaria allergen bronchial challenge

Interventions

house dust mite and alternaria allergen bronchial challenge BIOLOGICAL

2 ml of saline-dissolved lyophylised house dust mite or alternaria in concentration 5000 standard biological units (SBU/ml) The challenge is the only intervention. 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.

Also known as: Lyophylised allergen (Allergopharma, Rheinbeck, Germany)

house dust mite and alternaria allergy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Goethe University,

Frankfurt am Main, 60590, Germany

Location

Related Publications (5)

• Douglas TA, Kusel M, Pascoe EM, Loh RK, Holt PG, Sly PD. Predictors of response to bronchial allergen challenge in 5- to 6-year-old atopic children. Allergy. 2007 Apr;62(4):401-7. doi: 10.1111/j.1398-9995.2007.01329.x.

  PMID: 17362251 BACKGROUND

• Cockcroft DW, Murdock KY, Kirby J, Hargreave F. Prediction of airway responsiveness to allergen from skin sensitivity to allergen and airway responsiveness to histamine. Am Rev Respir Dis. 1987 Jan;135(1):264-7. doi: 10.1164/arrd.1987.135.1.264.

  PMID: 3800152 BACKGROUND

• Schulze J, Rosewich M, Riemer C, Dressler M, Rose MA, Zielen S. Methacholine challenge--comparison of an ATS protocol to a new rapid single concentration technique. Respir Med. 2009 Dec;103(12):1898-903. doi: 10.1016/j.rmed.2009.06.007. Epub 2009 Jul 10.

  PMID: 19596563 BACKGROUND

• Rosewich M, Rose MA, Eickmeier O, Travaci M, Kitz R, Zielen S. Montelukast as add-on therapy to beta-agonists and late airway response. Eur Respir J. 2007 Jul;30(1):56-61. doi: 10.1183/09031936.00063106. Epub 2007 Feb 14.

  PMID: 17301091 BACKGROUND

• Schulze J, Reinmuller W, Herrmann E, Rosewich M, Rose MA, Zielen S. Bronchial allergen challenges in children - safety and predictors. Pediatr Allergy Immunol. 2013 Feb;24(1):19-27. doi: 10.1111/pai.12031.

  PMID: 23331526 RESULT

MeSH Terms

Conditions

Dust Mite Allergy; Bronchial Hyperreactivity

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Johannes Schulze, Dr.

  Goethe University, Frankfurt, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant department of allergy, pulmonology, and cystic fibrosis

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2012
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

DE (1)