NCT02827721

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

5.3 years

First QC Date

June 30, 2016

Last Update Submit

March 23, 2020

Conditions

COPDObstructive Ventilation DisorderPulmonary Emphysema

Outcome Measures

Primary Outcomes (2)

  • lung clearance index (LCI) as determined by multiple breath washout

    30 minutes

  • airway resistance and reactance (R5, X5, R-D5-20) as determined by impulse oscillometry

    30 minutes

Secondary Outcomes (1)

  • repeatability of lung clearance index (LCI)

    30 minutes

Study Arms (2)

COPD

Patients with known or suspected COPD Patients with known or suspected obstructive ventilation disorder

Device: impulse oscillometryDevice: multiple breath washout testDevice: body plethysmography

pulmonary healthy controls

Patients without known or suspected pulmonary disease

Device: impulse oscillometryDevice: multiple breath washout testDevice: body plethysmography

Interventions

impulse oscillometryDEVICE
COPDpulmonary healthy controls
multiple breath washout testDEVICE
COPDpulmonary healthy controls
body plethysmographyDEVICE
COPDpulmonary healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with indication for routine lung function testing

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • inability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePulmonary Emphysema

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PlethysmographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory System

Central Study Contacts

Frederik Trinkmann, Dr.

CONTACT

+496213833879frederik.trinkmann@umm.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 11, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)