Safety and Repeatability of Bronchial Challenge With Grass-pollen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00507039
First received: July 23, 2007
Last updated: October 7, 2011
Last verified: October 2011
  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

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507039

Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
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
Study First Received: July 23, 2007
Last Updated: October 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 23, 2014