Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507039
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2007-07-23
Brief Title:
Safety and Repeatability of Bronchial Challenge With Grass-pollen
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Johann Wolfgang Goethe University Hospital
Study Overview
Official Title:
Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None