Safety and Repeatability of Bronchial Challenge With Grass-pollen

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Allergic Asthma

Treatments: Procedure: inhalative grass-pollen provocation

Study type: Observational

Funder types: Other

Identifiers

NCT00507039

334/06/FFM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

47 participants in 1 patient group

grass allergy, bronchial challenge

Description:

subjects with known allergy against grass-pollen undergo bronchial challenges

Treatment:

Procedure: inhalative grass-pollen provocation