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Safety and Repeatability of Bronchial Challenge With Grass-pollen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507039
First Posted: July 25, 2007
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
  Purpose
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.

Condition Intervention
Allergic Asthma Procedure: inhalative grass-pollen provocation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Repeatability of a Single Concentration and Single-step Bronchial Allergen Challenge With Grass Pollen

Resource links provided by NLM:


Further study details as provided by Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • repeatability of a bolus-dose inhalative allergen challenge with grass pollen [ Time Frame: feb 2007 - aug 2008 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Viasys APS, Allergopharma allergen

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507039


Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Stefan Zielen, M.D., Ph.D Goethe University, Department of Pulmonology
  More Information

Publications:
Responsible Party: Johannes Schulze MD, Cosultant Pediatric Allergy and Pulmonology, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00507039     History of Changes
Other Study ID Numbers: 334/06/FFM
First Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals:
PD20 FEV1
grass pollen
one-step