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Comparison of Two Methods of Bronchial Methacholine Provocation

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00503659
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
10
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bronchial methacholine provocation
  • Procedure: Bronchial methacholine provocation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

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

    		•
    Active Comparator: B

    Methacholine challenge five incremental dosages protocol

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. correlation of the two parameters PC20 FEV1 and PD20 FEV1 [feb 2007 - dec 2007]

    Secondary Outcome Measures

    1. kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration [see above]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Goethe University, Department of Pulmonology Frankfurt Hessen Germany 60590

    Sponsors and Collaborators

    • Johann Wolfgang Goethe University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johannes Schulze MD, Consultant Pediatric Allergy and Pulmonológy, Johann Wolfgang Goethe University Hospital
    ClinicalTrials.gov Identifier:
    NCT00503659
    Other Study ID Numbers:
    • 335/06/FFM
    First Posted:
    Jul 19, 2007
    Last Update Posted:
    Oct 12, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Johannes Schulze MD, Consultant Pediatric Allergy and Pulmonológy, Johann Wolfgang Goethe University Hospital
    PC20 FEV1
    PD20FEV1
    bronchial hyperreactivity
    bronchial asthma
    Additional relevant MeSH terms:
    Asthma
    Bronchial Hyperreactivity
    Methacholine Chloride

    Study Results

    No Results Posted as of Oct 12, 2011