Comparison of Two Methods of Bronchial Methacholine Provocation

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Bronchial Asthma; Bronchial Hyperreactivity

Treatments: Procedure: Bronchial methacholine provocation

Study type: Interventional

Funder types: Other

Identifiers

NCT00503659

335/06/FFM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

A

Active Comparator group

Description:

Methacholine challenge, five-breath dosimeter protocol

Treatment:

Procedure: Bronchial methacholine provocation

Procedure: Bronchial methacholine provocation

B

Active Comparator group

Description:

Methacholine challenge five incremental dosages protocol

Treatment:

Procedure: Bronchial methacholine provocation

Procedure: Bronchial methacholine provocation