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The study is meant to establish a one-step challenge with grass-pollen in patients sensitized for grass-pollen. Therefore the investigators compare a multi-step challenge with grass-pollen with an one-step challenge in order to survey the repeatability and safety.
Background:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| grass allergy, bronchial challenge | subjects with known allergy against grass-pollen undergo bronchial challenges |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhalative grass-pollen provocation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| repeatability of a bolus-dose inhalative allergen challenge with grass pollen | feb 2007 - aug 2008 |
| Measure | Description | Time Frame |
|---|---|---|
| kappa-index of concordance: reliability of the three procedures titrated skin prick-test, incremental challenge and bolus challenge with grass pollen. | feb 2007 - dec 2007 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects undergo allergen challenges with incremental doses of grass pollen allergen. In those subjects, who develop a fall in FEV1 of more than 20%, this is followed by two single-step challenges in an interval of at least seven days.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zielen, M.D., Ph.D | Goethe University, Department of Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University, Department of Pulmonology | Frankfurt am Main | Hesse | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 507521 | Background | 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. | |
| 3800152 |
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|
| 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. |