Comparison of Two Methods of Bronchial Methacholine Provocation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503659

Enrollment

Registered

2007-07-19

Start date

2007-02-28

Completion date

2007-12-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma, Bronchial Hyperreactivity

Keywords

PC20 FEV1, PD20FEV1, bronchial hyperreactivity, bronchial asthma

Brief summary

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

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.

Interventions

PROCEDUREBronchial 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
correlation of the two parameters PC20 FEV1 and PD20 FEV1	feb 2007 - dec 2007

Secondary

Measure	Time frame
kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration	see above

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026