Multiple Breath Washout, a Clinimetric Dataset
Multiple Breath Washout in Paediatric Chronic Airways Disease: Building a Clinimetrics Dataset
1 other identifier
observational
530
1 country
1
Brief Summary
Monitoring patients with chronic, inflammatory airways disease particularly in the early stages is hampered by the relative insensitivity of current outcome measures to detect subtle changes. Multiple breath washout is a potential sensitive test that is a useful readout of disease at these early stages but it lacks standardisation and knowledge of variability with reference to standard lung function measures. This is a Cross sectional and longitudinal observation study. The hypothesis is that multiple breath washout-derived indices will provide a robust signal of gas mixing inhomogeneity, correlating with conventional measures of airway disease severity. Multiple breath washout performed on different devices will generate indices which correlate but differ in value.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
1 active site
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
May 5, 2017
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedMay 6, 2022
May 1, 2022
6.8 years
May 17, 2017
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Lung Clearance Index
Multiple breath washout involves recording concentrations of a tracer gas whilst it is cleared from the lungs during normal tidal breathing. The tracer gas can either be an inert gas such as sulphur hexafluoride (SF6) that is washed out by room air, or resident Nitrogen (N2) that is cleared by 100% oxygen (O2). All tracer gases are traditionally cleared to 1/40th (or 2.5%) of their starting concentration. This procedure is performed in triplicate, each test will take around 5-10 minutes with wait time in-between.
Each testing session may take up to 90 minutes but most likely it will be under an hour. The MBW test will be completed at each visit and the LCI and other MBW results are obtained from data analysis post completion.
Secondary Outcomes (3)
Spirometry
Spirometry will be completed at each visit (unless already taken at a clinical visit). Maximum 10 visits over 3 years
Disease specific Quality of life questionnaire
The quality of life questionnaire will be completed at each visit and compared to the primary outcome at each visit. Maximum 10 visits over 3 years
Review of clinically indicated tests
Post each visit review of clinically indicated tests will take place and compared to the primary outcome. Maximum 10 visits over 3 years
Interventions
Multiple breath washout testing will be completed on different devices over time
Eligibility Criteria
Patients aged two and upwards with chronic airways disease including CF, PCD, Asthma and Bronchiectasis, Persistent bacterial bronchitis and sleep disordered breathing and obesity as well as aged matched healthy control patients will be approached to take part in the study. Healthy volunteers will only complete MBW and Spirometry for comparison with respiratory disease patients.
You may qualify if:
- For patients with the following respiratory disease, diagnosis confirmed by:
- CF: diagnosed by standard criteria
- PCD: diagnosed by ciliary beat frequency measurement, ciliary beat pattern analysis or electron microscopy of ciliary ultrastructure, or genetics
- Non-CF bronchiectasis: CT diagnosis of bronchiectasis and not fulfilling diagnostic criteria for CF or PCD
- Asthma: as diagnosed by standard diagnostic criteria of British Thoracic Society/Scottish Intercollegiate Guideline Network (BTS/SIGN) guidelines.
- Persistent bacterial bronchitis defined as a wet cough present for \>1 month, usually with bronchoscopic evidence of chronic infection, that resolves with appropriate antibiotic therapy
- Sleep Disordered Breathing.
- For healthy volunteers, these will be colleagues and staff contacts (including children) at a participating centre i.e. Royal Brompton Hospital, or will be siblings of patients.
- Written informed consent (assent from children of appropriate age) obtained.
You may not qualify if:
- Positive culture (within the last year of / receiving treatment for Mycobaterium tuberculosis or abscessus (due to cross-infection concerns).
- Pregnant or breastfeeding.
- Inability to understand or cooperate with the test(s).
- Inability to give informed consent, or withdrawal of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton Hospital
London, sw36lr, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane C Davies, Professor
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
October 25, 2017
Study Start
May 5, 2017
Primary Completion
March 1, 2024
Study Completion
March 1, 2024
Last Updated
May 6, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share