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Completed

NCT Number: NCT00503659

Comparison of Two Methods of Bronchial Methacholine Provocation

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.

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Key information

Conditions

Bronchial Hyperreactivity Asthma Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchial methacholine provocation

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)

Other names: DeVilbiss nebulizer

Primary outcomes

  1. correlation of the two parameters PC20 FEV1 and PD20 FEV1

    Time frame: 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

    Time frame: see above

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Comparison of Two Methods of Bronchial Methacholine Provocation: PC 20 FEV1 Versus PD 20 FEV1

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 19, 2007
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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