OXYPuF
Research type
Research Study
Full title
Ambulatory Oxygen for Idiopathic Pulmonary Fibrosis
IRAS ID
1004392
Contact name
Birgit Whitman
Contact email
Sponsor organisation
The University of Birmingham
Eudract number
2021-003535-29
ISRCTN Number
ISRCTN16366011
Research summary
Research Summary
The OXYPuF trial is trying to find out what is the best treatment and the most cost effective treatment for patients with idiopathic pulmonary fibrosis (IPF) by comparing the results from two groups of participants with IPF; one group will be given advice on breathlessness and the other group will be given advice on breathlessness AND oxygen to use whilst walking and doing other daily activities at home.
There is not currently an agreed best way to treat IPF patients with this condition who become breathless and their blood oxygen levels fall when they exercise - exercise in this context means simple walking. Some hospitals provide advice on how to manage this breathlessness, whilst others arrange for portable oxygen cylinders to be delivered to the patients home, which the patients can use if they feel breathless.
This trial will recruit 260 patients with IPF and randomly provide half of them with printed advice on breathlessness and half with the same advice AND oxygen to use when they become breathless.
Factors such as the patient's physical activity, cough and severity of symptoms will be measured over 6 months to find which of these approaches is the best for the patient and the relative cost of providing it.Summary of Results
The trial was stopped prematurely due to low recruitment. This was due to a combination of the impact of COVID-19 on research infrastructure, financial issues for sites with the payment structure for the trial and lack of equipoise which limited site recruitment. 7 of 25 patients eligible, interested patients were randomised after pre-screening, implying a lack of interest amongst patients in the study. Baseline characteristics indicated that patients were elderly (mean age 81) and predominantly male. Qualitative work with 11 patients and 23 other stakeholders concluded that ambulatory oxygen is desirable, acceptable and widely commissioned in the UK, such that further trials are not likely to be feasible. In conclusion, although we are not able to formally address our objectives of assessing efficacy and cost-effectiveness of ambulatory oxygen in idiopathic pulmonary fibrosis, it is unlikely that conducting another randomised clinical trial is feasible due to lack of equipoise.
REC name
HSC REC B
REC reference
22/NI/0053
Date of REC Opinion
25 May 2022
REC opinion
Further Information Favourable Opinion