Comparison of Two Methods of Bronchial Methacholine Provocation

Bronchial Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503659
• Other study ID #: 335/06/FFM
• Status: Completed
• Phase: N/A
• First received: July 18, 2007
• Last updated: October 7, 2011
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Bronchial Hyperreactivity

Intervention

Procedure:
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Goethe University, Department of Pulmonology	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of the two parameters PC20 FEV1 and PD20 FEV1		feb 2007 - dec 2007	No
Secondary	kappa index of concordance: reliability of the two procedures as to a FEV1 decrease of 20% depending on methacholine concentration		see above	No