Safety and Repeatability of Bronchial Challenge With Grass-pollen

Completed

• Conditions: Allergic Asthma
• Interventions: Procedure: inhalative grass-pollen provocation

• Registration Number: NCT00507039
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Primary Completion: 2008-09
• Study Completion: 2009-12
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• age >12 <45 years
• known sensitization for grass-pollen
• informed consent

Exclusion Criteria

• age <12 >45 years
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
grass allergy, bronchial challenge	inhalative grass-pollen provocation	subjects with known allergy against grass-pollen undergo bronchial challenges

Primary Outcome Measures

Name	Time	Method
repeatability of a bolus-dose inhalative allergen challenge with grass pollen	feb 2007 - aug 2008

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Goethe University, Department of Pulmonology; 🇩🇪 Frankfurt, Hessen, Germany