Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

June 2, 2017 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim

Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls

The investigators aim to determine the optimal number of measurements required for multiple-breath-washout derived lung function parameters in adults with pulmonary disease as well as in healthy controls

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

inpatients, outpatients, students, employees

Description

Inclusion criteria:

- informed consent

Exclusion Criteria:

  • inability to perform multiple breath washout testing

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
healthy controls
  • no history of pulmonary disease
  • absence of symptoms, smoking history < 10 pack years
  • normal lung function testing
Diagnostic test: multiple breath washout
determination of lung clearance index using SF6 multiple breath washout
chronic obstructive pulmonary disease
  • clinical history and/or specialist diagnosis of COPD and risk factor(s)
  • persistent bronchial obstruction and/or hyperinflation and/or radiological sign of emphysema, each without alternative explanation
  • dyspnea, cough and/or sputum production
Diagnostic test: multiple breath washout
determination of lung clearance index using SF6 multiple breath washout
bronchial asthma
  • clinical history and/or specialist diagnosis of bronchial asthma
  • respiratory symptoms compatible with asthma varying over time
  • variable and/or reversible obstructive ventilation disorder and/or airway hyperresponsiveness
  • exclusion of alternative explanation
Diagnostic test: multiple breath washout
determination of lung clearance index using SF6 multiple breath washout
sarcoidosis
  • clinical history and/or specialist diagnosis of sarcoidosis
  • lymphocytic alveolitis and CD4/CD8 > 3.5 in bronchoalveolar lavage and/or noncaseating epithelioid granuloma
  • exclusion of alternative explanation
Diagnostic test: multiple breath washout
determination of lung clearance index using SF6 multiple breath washout

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of lung clearance index (LCI) as determined by multiple breath washout
Time Frame: 60 minutes
comparing the repeatability of duplicate vs. triplicate LCI measurements
60 minutes

Collaborators and Investigators

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

Sponsor

Universitätsmedizin Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

June 30, 2016

Study Completion (ACTUAL)

January 15, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (ACTUAL)

June 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBW-number

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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