FIBRINOX-EXTRA version 1.0
Research type
Research Study
Full title
A prospective observational study investigating whether nocturnal hypoxaemia and exercise induced desaturation predict functional deterioration in patients with fibrotic interstitial lung disease
IRAS ID
329843
Contact name
Alex West
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The fibrotic interstitial lung diseases (FILD) are a group of diseases which all cause unexplained scarring of the lung, also known as pulmonary fibrosis. This group of diseases cause a restriction of breathing, and impaired function of the lung, resulting in breathlessness and reduced exercise capacity. Patients with FILD typically have a worse quality of life and increased mortality. Pulmonary hypertension (PH) is increased pressure in the blood vessels in the lungs. PH often complicates FILD and is associated with worse symptoms, exercise capacity, increased need for home oxygen and worse survival.
Our previous research confirmed that low oxygen levels at night, and dropping oxygen levels on exercise, are associated with a significant reduction in quality of life and increased mortality. This is probably due to a combination of worsening lung disease and the development of PH. We do not know why some patients develop progressive lung disease or PH but suspect that low oxygen levels at night and on exercise, measured using overnight sleep studies and 6-minute walk tests, can be used to identify patients who will develop progressive FILD or PH earlier. This will enable closer monitoring and earlier appropriate treatment.
This study will recruit patients from three tertiary ILD centres: Guy’s and St Thomas’, King’s and the Royal Brompton Hospital. We will collect data from routinely performed blood tests, lung function tests, a heart scans, overnight sleep studies, and perform health-related quality-of-life questionnaires at baseline. We will then collect data from these routinely performed tests again at 6 months and 12 months (excluding the heart scan), and repeat the questionnaires at 6 months and 12 months also.
A 3 year from enrolment electronic health record check will be completed to collect data on mortality and confirmed diagnoses of pulmonary hypertension. No further data will be collected after this point.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
24/WM/0125
Date of REC Opinion
11 Jun 2024
REC opinion
Further Information Favourable Opinion