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Completed

NCT Number: NCT00507039

Safety and Repeatability of Bronchial 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.

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Key information

Conditions

Allergic Asthma

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhalative grass-pollen provocation

Procedure

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

Primary outcomes

  1. repeatability of a bolus-dose inhalative allergen challenge with grass pollen

    Time frame: feb 2007 - aug 2008

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Jul 25, 2007
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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