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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

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
        • University Medical Center Mannheim
        • Principal Investigator:
          • Saur Joachim, Prof. Dr.
        • Principal Investigator:
          • Henzler Thomas, Prof. Dr.

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with indication for routine lung function testing

Description

Inclusion Criteria:

  • known or suspected COPD
  • known or suspected obstructive ventilation disorder
  • pulmonary healthy controls

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 healthy controls
Patients without known or suspected pulmonary disease
Device: impulse oscillometry
Device: multiple breath washout test
Device: body plethysmography
COPD
Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder
Device: impulse oscillometry
Device: multiple breath washout test
Device: body plethysmography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lung clearance index (LCI) as determined by multiple breath washout
Time Frame: 30 minutes
30 minutes
airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
repeatability of lung clearance index (LCI)
Time Frame: 30 minutes
30 minutes

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

July 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (ESTIMATE)

July 11, 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-COPD

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.

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