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NCT02827721 Clinical Trial

Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02827721
Other study ID # MBW-COPD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2015
Est. completion date November 2020

Study information
Verified date March 2020
Source Universitätsmedizin Mannheim
Contact Frederik Trinkmann, Dr.
Phone +496213833879
Email frederik.trinkmann@umm.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of COPD.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- known or suspected COPD

- known or suspected obstructive ventilation disorder

- pulmonary healthy controls

Exclusion Criteria:

- pregnancy

- inability to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• impulse oscillometry

• multiple breath washout test

• body plethysmography

Locations
Country Name City State
Germany University Medical Center Mannheim Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary lung clearance index (LCI) as determined by multiple breath washout 30 minutes
Primary airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry 30 minutes
Secondary repeatability of lung clearance index (LCI) 30 minutes
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