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Comparison of Two Methods of Bronchial Methacholine Provocation

NCT ID: NCT00503659

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Bronchial Hyperreactivity Bronchial Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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A

Methacholine challenge, five-breath dosimeter protocol

Group Type ACTIVE_COMPARATOR

Bronchial methacholine provocation

Intervention Type PROCEDURE

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

Methacholine challenge five incremental dosages protocol

Group Type ACTIVE_COMPARATOR

Bronchial methacholine provocation

Intervention Type PROCEDURE

A five-step protocol using a single dilution of 16 mg/ml methacholine (0.01, 0.1, 0.4, 0.8, 1.6 mg)

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Other Intervention Names

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DeVilbiss nebulizer Viasys APS nebulizer

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Johannes Schulze MD

Consultant Pediatric Allergy and Pulmonológy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Zielen, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Goethe University, Department of Pulmonology

Locations

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Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 10619836 (View on PubMed)

Other Identifiers

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335/06/FFM

Identifier Type: -

Identifier Source: org_study_id