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
  Purpose

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 Intervention
Bronchial Hyperreactivity
Bronchial Asthma
Procedure: Bronchial methacholine provocation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • correlation of the two parameters PC20 FEV1 and PD20 FEV1 [ Time Frame: feb 2007 - dec 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Viasys APS nebulizer

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.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00503659

Locations
Germany
Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Stefan Zielen, M.D., Ph.D. Goethe University, Department of Pulmonology
  More Information

Publications:
Responsible Party: Johannes Schulze MD, Consultant Pediatric Allergy and Pulmonológy, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00503659     History of Changes
Other Study ID Numbers: 335/06/FFM
Study First Received: July 18, 2007
Last Updated: October 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
PC20 FEV1
PD20FEV1
bronchial hyperreactivity
bronchial asthma

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014