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Comparison of Two Methods of Bronchial Methacholine Provocation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00503659
First received: July 18, 2007
Last updated: October 7, 2011
Last verified: October 2011
History of Changes

July 18, 2007
October 7, 2011
February 2007
December 2007   (final data collection date for primary outcome measure)
correlation of the two parameters PC20 FEV1 and PD20 FEV1 [ Time Frame: feb 2007 - dec 2007 ] [ Designated as safety issue: No ]
correlation of the two parameters PC20 FEV1 and PD20 FEV1 [ Time Frame: feb 2007 - dec 2007 ]
Complete list of historical versions of study NCT00503659 on ClinicalTrials.gov Archive Site
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration [ Time Frame: see above ] [ Designated as safety issue: No ]
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on metacholine concentration [ Time Frame: see above ]
Not Provided
Not Provided
 
Comparison of Two Methods of Bronchial Methacholine Provocation
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Bronchial Hyperreactivity
  • Bronchial Asthma
  • 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 Name: 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 Name: Viasys APS nebulizer
  • Active Comparator: A
    Methacholine challenge, five-breath dosimeter protocol
    Intervention: Procedure: Bronchial methacholine provocation
  • Active Comparator: B
    Methacholine challenge five incremental dosages protocol
    Intervention: Procedure: Bronchial methacholine provocation
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00503659
335/06/FFM
Yes
Johannes Schulze MD, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of Pulmonology
Johann Wolfgang Goethe University Hospitals
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP