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NCT02826265 Clinical Trial

Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Evaluation of Novel Lung Function Parameters and Quantitative Computed Tomography (qCT) in Patients With Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02826265
Other study ID # MBW-qCT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date December 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 diagnostic tools used in pulmonary disease often do not meet the challenges set by the respective pathophysiology. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and therapeutic monitoring of patients with various pulmonary diseases.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- known or suspected pulmonary lung disease

- indication for computed tomography

Exclusion Criteria:

- pregnancy

- inability to participate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• multiple breath washout test (MBW)

• impulse oscillometry (IOS)

• body plethysmography (BP)

• quantitative computed tomography (qCT)
ultra-low-dose qCT

Locations
Country Name City State
Germany Universitätsmedizin 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 correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT 2 weeks
Primary correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT 2 weeks
Primary correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT 2 weeks
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