Clinical Trial: Comparison of Two Methods of Bronchial Methacholine Provocation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1

Brief Summary: This study is meant to compare two routine diagnostic approaches in patients with bronchial asthma. Patients are challenged with methacholine in order to measure their bronchial response. We compare the evaluation of the effects of incremental concentrations versus incremental dosages.

Detailed Summary: Bronchial methacholine challenge is well established in asthma diagnostic and research purposes. ATS guidelines provide a short five-breath dosimeter protocol using a five-step dilution schedule. The Viasys APS system enables a feasible and less time consuming provocation with incremental dosages. In 48 young adults with bronchial hyperreactivity (BHR) the ATS-protocol with a five-step protocol using a single dilution of 16 mg/ml methacholine should be compared.
Sponsor: Johann Wolfgang Goethe University Hospital

Current Primary Outcome: correlation of the two parameters PC20 FEV1 and PD20 FEV1 [ Time Frame: feb 2007 - dec 2007 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration [ Time Frame: see above ]

Original Secondary Outcome: kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on metacholine concentration [ Time Frame: see above ]

Information By: Johann Wolfgang Goethe University Hospital

Dates:
Date Received: July 18, 2007
Date Started: February 2007
Date Completion:
Last Updated: October 7, 2011
Last Verified: October 2011