Ambulatory oxygen and health status in patients with lung fibrosis
Research type
Research Study
Full title
Randomised, controlled crossover trial to evaluate the Effects of Ambulatory Oxygen on health status in patients with Fibrotic Lung Disease (FLD)
IRAS ID
141158
Contact name
Elisabetta Renzoni
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Eudract number
2013-004355-20
Research summary
Fibrotic Lung Diseases(FLDs) are chronic conditions resulting in substantial morbidity and mortality. Progressive scarring of lungs is responsible for pulmonary function impairment. Breathlessness is the hallmark symptom of FLD referred by patients as a need to limit activities and to take time to recover after exertion. Moreover, anxiety, depression and fatigue commonly affect individual’s sense of well-being. Unfortunately, pharmacological therapy is limited in FLD, so attempts to improve or maintain health status are of crucial importance.
Breathlessness on exertion reflects a drop in oxygen levels in the blood from the normal level (>94%) to critical values (<88%) during exercise and supplemental oxygen can correct it. This gap can be defined by performing the six minute walk test (6MWT) which is the most validated test that reflects daily activities. Interestingly, there are no international guidelines for oxygen therapy in FLDs.
We aim to explore the benefits of oxygen use when performing activities (“ambulatory oxygen“) on day to day breathlessness, quality of life and mobility in patients with FLDs whose oxygen saturation falls < 88% on a 6MWT. We also aim to assess whether the improvement in 6MWT performance induced by portable oxygen can predict benefit of ambulatory oxygen in daily living.
The study will consist of comparisons of breathlessness, quality of life and mobility at the end of two weeks on ambulatory oxygen compared to no ambulatory oxygen supply for the same period in 80 patients with FLDs. We also propose to explore in interviews patients’ and carers’ experiences of the use of a portable oxygen supply in a subgroup of 20 patients and carers. These interviews will provide patient-derived expectations and any concerns over the psychological and practical barriers faced when using ambulatory oxygen and any suggestions on how to improve the provision and future design of ambulatory oxygen devices.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0258
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion