Safety and Repeatability of Bronchial Challenge With Grass-pollen

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Asthma
• Intervention / Treatment: Procedure: inhalative grass-pollen provocation

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 Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Goethe University, Department of Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
grass allergy, bronchial challenge; subjects with known allergy against grass-pollen undergo bronchial challenges	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.; Other Names: Viasys APS, Allergopharma allergen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
repeatability of a bolus-dose inhalative allergen challenge with grass pollen	feb 2007 - aug 2008

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: Stefan Zielen, M.D., Ph.D, Goethe University, Department of Pulmonology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 23, 2007
• First Submitted That Met QC Criteria: July 23, 2007
• First Posted (Estimate): July 25, 2007

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: PD20 FEV1; grass pollen; one-step
• Other Study ID Numbers: 334/06/FFM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No