Comparison of Two Methods of Bronchial Methacholine Provocation
- Conditions
- Bronchial HyperreactivityBronchial Asthma
- Registration Number
- NCT00503659
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Informed consent
- Age 12-45 years
- Known bronchial hyperreactivity
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method correlation of the two parameters PC20 FEV1 and PD20 FEV1 feb 2007 - dec 2007
- Secondary Outcome Measures
Name Time Method kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration see above
Trial Locations
- Locations (1)
Goethe University, Department of Pulmonology
🇩🇪Frankfurt, Hessen, Germany
Goethe University, Department of Pulmonology🇩🇪Frankfurt, Hessen, Germany