Comparison of Two Methods of Bronchial Methacholine Provocation
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedOctober 12, 2011
October 1, 2011
10 months
July 18, 2007
October 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
correlation of the two parameters PC20 FEV1 and PD20 FEV1
feb 2007 - dec 2007
Secondary Outcomes (1)
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration
see above
Study Arms (2)
A
ACTIVE COMPARATORMethacholine challenge, five-breath dosimeter protocol
B
ACTIVE COMPARATORMethacholine challenge five incremental dosages protocol
Interventions
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)
Eligibility Criteria
You may qualify if:
- Informed consent
- Age 12-45 years
- Known bronchial hyperreactivity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
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.
PMID: 10619836BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zielen, M.D., Ph.D.
Goethe University, Department of Pulmonology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Pediatric Allergy and Pulmonológy
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 19, 2007
Study Start
February 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
October 12, 2011
Record last verified: 2011-10