NCT03320382

Multiple Breath Washout, a Clinimetric Dataset

Multiple Breath Washout in Paediatric Chronic Airways Disease: Building a Clinimetrics Dataset

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 530 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Cystic Fibrosis
• Primary Ciliary Dyskinesia
• Bronchiectasis
• Asthma
• Bronchitis
• Sleep Disorder

Interventions

Type	Name	Description
DEVICE	Multiple breath washout testing	Multiple breath washout testing will be completed on different devices over time

Timeline

• Start date: 2017-05-05
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2017-10-25
• Last updated: 2022-05-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study