Safety and Repeatability of Bronchial Challenge With Grass-pollen

October 7, 2011 updated by: Johannes Schulze MD, Johann Wolfgang Goethe University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: feb 2007 - aug 2008
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.
Time Frame: feb 2007 - dec 2007
feb 2007 - dec 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Stefan Zielen, M.D., Ph.D, Goethe University, Department of Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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