Safety and Repeatability of Bronchial Challenge With Grass-pollen

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507039
• Other study ID #: 334/06/FFM
• Status: Completed
• Phase: N/A
• First received: July 23, 2007
• Last updated: October 7, 2011
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Allergic Asthma

Intervention

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.

Locations

Country	Name	City	State
Germany	Goethe University, Department of Pulmonology	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	repeatability of a bolus-dose inhalative allergen challenge with grass pollen		feb 2007 - aug 2008	No
Secondary	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	No