Back to resultsComparison of Two Methods of Bronchial Methacholine Provocation
Primary Purpose
Bronchial Hyperreactivity, Bronchial Asthma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bronchial methacholine provocation
Bronchial methacholine provocation
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchial Hyperreactivity focused on measuring PC20 FEV1, PD20FEV1, bronchial hyperreactivity, bronchial asthma
Eligibility Criteria
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
Sites / Locations
- Goethe University, Department of Pulmonology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Methacholine challenge, five-breath dosimeter protocol
Methacholine challenge five incremental dosages protocol
Outcomes
Primary Outcome Measures
correlation of the two parameters PC20 FEV1 and PD20 FEV1
Secondary Outcome Measures
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration
Full Information
NCT ID
NCT00503659
First Posted
July 18, 2007
Last Updated
October 7, 2011
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00503659
Brief Title
Comparison of Two Methods of Bronchial Methacholine Provocation
Official Title
Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Hyperreactivity, Bronchial Asthma
Keywords
PC20 FEV1, PD20FEV1, bronchial hyperreactivity, bronchial asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Methacholine challenge, five-breath dosimeter protocol
Arm Title
B
Arm Type
Active Comparator
Arm Description
Methacholine challenge five incremental dosages protocol
Intervention Type
Procedure
Intervention Name(s)
Bronchial methacholine provocation
Other Intervention Name(s)
DeVilbiss nebulizer
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Bronchial methacholine provocation
Other Intervention Name(s)
Viasys APS nebulizer
Intervention Description
A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)
Primary Outcome Measure Information:
Title
correlation of the two parameters PC20 FEV1 and PD20 FEV1
Time Frame
feb 2007 - dec 2007
Secondary Outcome Measure Information:
Title
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration
Time Frame
see above
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Zielen, M.D., Ph.D.
Organizational Affiliation
Goethe University, Department of Pulmonology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe University, Department of Pulmonology
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
10619836
Citation
Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.
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Comparison of Two Methods of Bronchial Methacholine Provocation
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