NCT02826239

Brief Summary

The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

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

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

4.8 years

First QC Date

June 30, 2016

Last Update Submit

March 23, 2020

Conditions

Pulmonary Healthy ControlsPulmonary Disease

Outcome Measures

Primary Outcomes (1)

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

    60 minutes

Secondary Outcomes (1)

  • repeatability of lung clearance index (LCI)

    60 minutes

Study Arms (2)

pulmonary healthy controls

patients without known pulmonary disease

Device: multiple breath washout test (MBW)

pulmonary disease

patients with known or suspected pulmonary disease

Device: multiple breath washout test (MBW)

Interventions

multiple breath washout test (MBW)DEVICE

measured in upright and supine position

pulmonary diseasepulmonary healthy controls

Eligibility Criteria

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

patients with and without known pulmonary disease

You may qualify if:

  • patients with and without known pulmonary disease

You may not qualify if:

  • pregnancy
  • inability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Frederik Trinkmann, Dr.

CONTACT

+496213833879frederik.trinkmann@umm.de

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
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 7, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)