Comparison of Two Methods of Bronchial Methacholine Provocation

October 7, 2011 updated by: Johannes Schulze MD, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Goethe University, Department of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Age 12-45 years
  • Known bronchial hyperreactivity

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Methacholine challenge, five-breath dosimeter protocol
Procedure: Bronchial methacholine provocation
A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)
Other Names:
  • DeVilbiss nebulizer
Procedure: Bronchial methacholine provocation
A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
Other Names:
  • Viasys APS nebulizer
Active Comparator: B
Methacholine challenge five incremental dosages protocol
Procedure: Bronchial methacholine provocation
A short five-breath dosimeter protocol using a five-step dilution schedule according to ATS guidelines (0.0625, 0.25, 1, 4, 16 mg/ml methacholine)
Other Names:
  • DeVilbiss nebulizer
Procedure: Bronchial methacholine provocation
A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
Other Names:
  • Viasys APS nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation of the two parameters PC20 FEV1 and PD20 FEV1
Time Frame: feb 2007 - dec 2007
feb 2007 - dec 2007

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Stefan Zielen, M.D., Ph.D., Goethe University, Department of Pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 335/06/FFM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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