NCT00507039

Safety and Repeatability of Bronchial Challenge With Grass-pollen

Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-09-01
• Completion: 2009-12-01
• First posted: 2007-07-25
• Last updated: 2011-10-12

Locations

1 site across 1 country: Germany