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Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction.

NCT01134757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2023-03-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Johannes Schulze, Dr. · Goethe University, Frankfurt, Germany

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-12-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134757 on ClinicalTrials.gov