Effect of Bronchodilatator Testing on Multiple-breath-washout (MBW) Derived Lung Function Parameters

December 30, 2018 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
The investigators aim to evaluate the effect of bronchodilatator testing on multiple-breath-washout derived lung function parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

145

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
        • Universitätsmedizin Mannheim

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 known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing

Description

Inclusion Criteria:

  • known or suspected obstructive ventilation disorder
  • clinical indication for bronchodilator testing

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obstructive ventilation disorder
patients with known or suspected obstructive ventilation disorder and clinical indication for bronchodilator testing
Device: multiple-breath-washout test
Drug: Bronchodilator Agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of lung clearance index (LCI) as determined by multiple breath washout
Time Frame: 60 minutes
60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
repeatability of lung clearance index (LCI)
Time Frame: 60 minutes
60 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 (Actual)

May 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

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)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 30, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBW-bronchodilator

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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