Multiple Breath Washout, a Clinimetric Dataset
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|ClinicalTrials.gov Identifier: NCT03320382|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment|
|Cystic Fibrosis Primary Ciliary Dyskinesia Bronchiectasis Asthma Bronchitis Sleep Disorder||Device: Multiple breath washout testing|
Lung Clearance Index (LCI) has been shown to be more sensitive and perhaps more applicable in early stages of lung disease when compared to currently utilised physiological outcome measures, and yet it is not approved by regulatory agencies as a recognised surrogate outcome measure. This may highlight some of the lack of understanding within MBW; what is the best equipment to use, what is the minimal value of change to show an improvement in LCI, what is LCI's correlation with clinical outcome measures and what does the progression of LCI tell us about lung disease. These questions will be addressed with a view to contributing a body of data to guide decisions around its utility in both interventional drug trials and for monitoring in a clinical setting.
The aim of this study is to assess the suitability of LCI as a clinical outcome measure for both clinical trials and clinical monitoring of patients with inflammatory respiratory disease across the disease spectrum. Different testing modalities will be compared as well as assess the repeatability and validity of LCI for its determination as an outcome measure. Long-term follow up will allow an assessment of the relationship between LCI and future outcomes such as rate of decline in lung function and frequency of exacerbations, both recognised as relevant by regulatory agencies.
|Study Type :||Observational|
|Estimated Enrollment :||530 participants|
|Official Title:||Multiple Breath Washout in Paediatric Chronic Airways Disease: Building a Clinimetrics Dataset|
|Actual Study Start Date :||May 5, 2017|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
- Device: Multiple breath washout testing
Multiple breath washout testing will be completed on different devices over timeOther Names:
- Exhlayzer D (Ecomedics)
- Modified Innocor (Innovision)
- Amis 2000 (Respiratory Mass Spectrometer) (Innovision)
- EasyOne Pro (New Diagnostic Design (NDD) Medical Technologies Inc
- Lung Clearance Index [ Time Frame: 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. ]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.
- Spirometry [ Time Frame: Spirometry will be completed at each visit (unless already taken at a clinical visit). Maximum 10 visits over 3 years ]Spirometry is an effort dependant test designed to assess lung volumes.Spirometry will be performed according to ERS guidelines on a spirometer such as the Easyone with a disposable mouthpiece and filter. Three good quality measurements will be made and the best recorded in absolute values. Spirometry will only be collected in subjects age 6 and upwards (or if performed adequately at clinic visits at a younger age) since it is difficult to perform and produce reliable spirometry results in this young age
- Disease specific Quality of life questionnaire [ Time Frame: 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 ]
Quality of Life Questionnaires provide patient-reported outcomes and how subjects are feeling in relation to new treatments or generally with regard to their lung disease. For certain diseases such as cystic fibrosis, these outcome measures are emerging as clinical tools, so it will not be duplicated if it has already been performed. A questionnaire will be completed either on paper or a computer at each visit to compare physiological data with how a patient is feeling.
Validated Revised Cystic Fibrosis Questionnaire (CFQR) for CF patients. For Asthma patients, Paediatric Asthma Quality of life Questionnaire, Paediatric Asthma Caregivers Quality of Life Questionnaire, Asthma Control Test Score, Childhood Asthma Control Test score, Test for Respiratory and Asthma Control in Kids.
For Primary Cilary Dyskinesia the new validated PCD questionnaire. Healthy volunteers will not complete a questionnaire.
- Review of clinically indicated tests [ Time Frame: Post each visit review of clinically indicated tests will take place and compared to the primary outcome. Maximum 10 visits over 3 years ]For patients with respiratory disease, some results taken for clinically indicated reasons either on the same day or close to the research day may be reviewed from clinical notes or hospital electronic data capture systems as part of this research for comparisons. These may include blood sample results, sputum cultures and clinically assessment from the multidisciplinary team within clinic letters.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320382
|Contact: Katie J Bayfieldemail@example.com|
|Contact: Clare Saundersfirstname.lastname@example.org|
|Principal Investigator:||Jane C Davies, Professor||Imperial College London|