Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
Determination of the Optimal Number of Multiple Breath Washout Tests in Adults With Pulmonary Disease and Healthy Controls
1 other identifier
observational
153
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2017
CompletedFirst Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedJune 5, 2017
June 1, 2017
1 year
June 2, 2017
June 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
change of lung clearance index (LCI) as determined by multiple breath washout
comparing the repeatability of duplicate vs. triplicate LCI measurements
60 minutes
Study Arms (4)
healthy controls
* no history of pulmonary disease * absence of symptoms, smoking history \< 10 pack years * normal lung function testing
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
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
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
Interventions
determination of lung clearance index using SF6 multiple breath washout
Eligibility Criteria
inpatients, outpatients, students, employees
You may qualify if:
- \- informed consent
You may not qualify if:
- inability to perform multiple breath washout testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Trinkmann F, Gotzmann J, Saur D, Schroeter M, Roth K, Stach K, Borggrefe M, Saur J, Akin I, Michels JD. Multiple breath washout testing in adults with pulmonary disease and healthy controls - can fewer measurements eventually be more? BMC Pulm Med. 2017 Dec 11;17(1):185. doi: 10.1186/s12890-017-0543-y.
PMID: 29228942DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 5, 2017
Study Start
July 1, 2015
Primary Completion
June 30, 2016
Study Completion
January 15, 2017
Last Updated
June 5, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share