Clinical trial
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.
Name
KGU-17/10
Description
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.
Trial arms
Trial start
2011-01-01
Estimated PCD
2011-12-01
Trial end
2012-10-01
Status
Completed
Treatment
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.
Arms:
house dust mite and alternaria allergy
Other names:
Lyophylised allergen (Allergopharma, Rheinbeck, Germany)
Size
425
Primary endpoint
Safety of bronchial allergen challenge with house dust mite and alternaria.
10 hours
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 425, 'type': 'ACTUAL'}}
Updated at
2023-03-13
1 organization
1 product
2 indications
Organization
Johann Wolfgang Goethe University HospitalIndication
House Dust Mite AllergyIndication
Bronchial hyperresponsiveness