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

March 23, 2020 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim
        • Principal Investigator:
          • Joachim Saur, Prof. Dr.
        • Principal Investigator:
          • Thomas Henzler, Prof. Dr.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with indication for routine lung function testing and computed tomography

Description

Inclusion Criteria:

  • known or suspected pulmonary lung disease
  • indication for computed tomography

Exclusion Criteria:

  • pregnancy
  • inability to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pulmonary disease
patients with known or suspected pulmonary disease
Device: multiple breath washout test (MBW)
Device: impulse oscillometry (IOS)
Device: body plethysmography (BP)
Device: quantitative computed tomography (qCT)
ultra-low-dose qCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation of lung clearance index (LCI) as determined by multiple breath washout with emphysema quantification as determined by qCT
Time Frame: 2 weeks
2 weeks
correlation of airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry with emphysema quantification as determined by qCT
Time Frame: 2 weeks
2 weeks
correlation of residual volume and airway resistance as determined by body plethysmography with and emphysema quantification as determined by qCT
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBW-qCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on multiple breath washout test (MBW)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe