Safety and Repeatability of Bronchial Challenge With Grass-pollen
NCT ID: NCT00507039
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2007-02-28
2009-12-31
Brief Summary
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Detailed Description
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Specific provocation with inhaled allergens is an established tool in clinical practice and research, supporting the understanding of pathophysiology of allergic asthma, and analysing the efficacy of new therapies. This study examines the repeatability of a bolus-dose inhalative allergen challenge with grass pollen.
Method:
Forty grass pollen allergics should undergo an incremental-dose grass pollen challenge to calculate their PD20-dose. This calculated dose will be applicated twice to analyse the repeatability of the bolus dose challenge. Before and twenty-four hours after the provocation, exhaled nitric oxid (FeNO) will be determined as a marker of bronchial inflammation.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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grass allergy, bronchial challenge
subjects with known allergy against grass-pollen undergo bronchial challenges
inhalative grass-pollen provocation
Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
Interventions
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inhalative grass-pollen provocation
Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In subjects, who develop a fall in FEV1 of more than 20%, this will be followed by two single-step challenges.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* known sensitization for grass-pollen
* informed consent
Exclusion Criteria
* clinical asthma requiring regular inhalation
* vital capacity \<80%
* FEV1 \< 75%
* chronic disease conditions or infections
* pregnancy
* inhalative or systemic steroid use
* substance abuse
* incapability of understanding the study's purpose and performance
12 Years
45 Years
ALL
Yes
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Johannes Schulze MD
Cosultant Pediatric Allergy and Pulmonology
Principal Investigators
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Stefan Zielen, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Goethe University, Department of Pulmonology
Locations
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Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, Germany
Countries
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References
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Cockcroft DW, Ruffin RE, Frith PA, Cartier A, Juniper EF, Dolovich J, Hargreave FE. Determinants of allergen-induced asthma: dose of allergen, circulating IgE antibody concentration, and bronchial responsiveness to inhaled histamine. Am Rev Respir Dis. 1979 Nov;120(5):1053-8. doi: 10.1164/arrd.1979.120.5.1053. No abstract available.
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.
Other Identifiers
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334/06/FFM
Identifier Type: -
Identifier Source: org_study_id