Comparison of Two Methods of Bronchial Methacholine Provocation - Full Text View

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00503659

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:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Methacholine Methacholine chloride

U.S. FDA Resources

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
A: Active Comparator 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)
B: Active Comparator 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)

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503659

Locations

Germany, Hessen
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:

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.

Responsible Party:	Johann Wolfgang Goethe University Hospitals ( Prof. Stefan Zielen )
Study ID Numbers:	335/06/FFM
Study First Received:	July 18, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00503659 History of Changes
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

Study placed in the following topic categories:

Neurotransmitter Agents
Bronchial Diseases
Miotics
Asthma
Cholinergic Agents
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Lung Diseases
Methacholine Chloride
Hypersensitivity, Immediate
Bronchial Hyperreactivity
Peripheral Nervous System Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Bronchoconstrictor Agents
Physiological Effects of Drugs
Cholinergic Agents
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Immune System Diseases
Miotics
Asthma
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Methacholine Chloride
Hypersensitivity, Immediate
Muscarinic Agonists
Bronchial Hyperreactivity
Peripheral Nervous System Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009