NCT01134757

Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• House Dust Mite Allergy
• Bronchial Hyperresponsiveness

Interventions

Type	Name	Description
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) 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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2012-10-01
• First posted: 2010-06-02
• Last updated: 2023-03-13

Locations

1 site across 1 country: Germany