What is the best treatment and the most cost effective treatment for patients with idiopathic pulmonary fibrosis (IPF): advice on breathlessness, or advice on breathlessness and oxygen to use whilst walking and doing other daily activities at home?
| ISRCTN | ISRCTN16366011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16366011 |
| EudraCT/CTIS number | 2021-003535-29 |
| IRAS number | 1004392 |
| Secondary identifying numbers | RG_20-147, IRAS 1004392 |
- Submission date
- 19/02/2022
- Registration date
- 27/05/2022
- Last edited
- 16/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
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 whose 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 patient's home, which the patients can use if they feel breathless.
Who can participate?
This trial will recruit 260 patients with IPF
What does the study involve?
Participants will be randomly allocated to receive printed advice on breathlessness, or 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.
What are the possible benefits and risks of participating?
Benefits:
No identifiable benefits except contributing to a better understanding of the best treatment for future patients with this condition.
Risks:
There are no clinically identified risks of using oxygen cylinders at home with patients in this cohort. It is stated as part of the inclusion/exclusion criteria that a patient should only be approached to take part in this trial if the responsible clinician believes there are no known risks specific to that patient using oxygen. As the other arm in the trial does not provide oxygen and simply provides printed advice on breathlessness there are no associated risks with this intervention. To minimise any confounding variables, the breathlessness advice sheet will be standardised and the same for both groups. In the arm who receive home oxygen cylinders, a phone call will be made 1 week after randomisation to ensure they are able to use the cylinders and to escalate any issues the participants have with the clinical team. Participants will be given contact numbers of the clinical team looking after them as well as the trials office should they need to ask any questions or raise any concerns. Participants will be asked to attend three appointments in total to take part in the study: baseline; 3-month follow; and 6-month follow-up. Baseline and 6-month follow-up appointments will be conducted in the hospital setting as well as completion of the participant completed booklet. These booklets may be completed by the participant within the clinic setting and handed to the research nurse who will then return them to the trial office, however, participants will be provided with pre-paid envelopes to return the patient-completed booklets directly to the trial office should they complete them at home. If participants who are approached to take part in the qualitative study agree to take part will be asked to spend approximately 60 minutes with a qualitative researcher who will conduct an interview regarding their experience with their condition and using home oxygen.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
February 2022 to December 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Matthew Soden, oxypuf@trials.bham.ac.uk
Contact information
Scientific
OXYPuF Trial Office
Public Health Building (Y17)
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 121 415 8444 |
|---|---|
| oxypuf@trials.bham.ac.uk |
Study information
| Study design | Interventional randomized parallel group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Scientific title | Ambulatory oxygen for idiopathic pulmonary fibrosis |
| Study acronym | OXYPuF |
| Study objectives | The OXYPuF trial is trying to find out what is the best treatment and most cost-effective treatment for patients with idiopathic pulmonary fibrosis (IPF) by comparing two arms; arm one receives advice on breathlessness; arm two receives advice on breathlessness AND the use of oxygen |
| Ethics approval(s) |
Approved 25/05/2022, Health and Social Care Research Ethics Committee B (HSC REC B) (-, Belfast, -, United Kingdom; +44 (0)28 9536 1400; RECB@hscni.net), ref: 2/NI/0053 |
| Health condition(s) or problem(s) studied | Idiopathic pulmonary fibrosis (IPF) |
| Intervention | 2-armed unblinded RCT Arm 1: Supply of ambulatory oxygen (home oxygen cylinders) and breathlessness advice Arm 2: Breathlessness advice only. Follow up is 6 months (randomised intervention remains in place during this follow up period unless clinically indicated otherwise/withdrawal). Randomisation is done via an online tool. |
| Intervention type | Mixed |
| Primary outcome measure | The King's Brief Interstitial Lung Disease (K-BILD) score at baseline and 6 months |
| Secondary outcome measures | Subscales within K-BILD (breathlessness, activity, chest symptoms) at baseline, 3 months and 6 months post randomisation: 1. Exercise capacity using the 6MWT or 1 minute sit to stand 2. MRC dyspnoea score 3. Physical activity using the IPAQ 4. Sleepiness using the Epworth Sleepiness Scale 5. Hospitalisations (all cause and IPF specific) 6. Cough using a 6 point Visual Analogue Scale (VAS) 7. Targeted adverse events 8. Mortality (6 months, and from medical record only at 12 months) 9. Medication use: benzodiazepines, antifibrotics; ACEis and opiates for breathlessness 10. Completion of pulmonary rehabilitation 11. Acceptability of AOT 12. Cost-effectiveness (using EQ-5D-5L, and scheduled and unscheduled health service use relating to IPF). |
| Overall study start date | 16/02/2022 |
| Completion date | 29/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 260 |
| Total final enrolment | 7 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Clinically diagnosed IPF, confirmed by an ILD MDT linked to an NHS specialist commissioned IPF service 3. Breathlessness with MRC dyspnoea score ≥2 4. Willing and able to comply with completion of questionnaires out to 6 months post-randomisation 5. Able to complete a 6MWT or 1 minute sit to stand test 6. Able to use oxygen safely in the opinion of the local investigator |
| Key exclusion criteria | 1. Unable to provide informed consent 2. Requires LTOT, defined by need for resting oxygen in the opinion of the local investigator 3. Life expectancy <6 months 4. On the active transplant list 5. Previous acidotic hypercapnic respiratory failure (AHRF) requiring non-invasive ventilation (NIV) |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 30/03/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sponsor information
University/education
Aston Webb Building Block B, Room 106
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 781 465 0003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 16/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Peer reviewed scientific journals Internal report Conference presentation Publication on website |
| IPD sharing plan | Via full execution of a data sharing agreement between the University of Birmingham and the organisation that requests the specific data to be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 18/12/2024 | 16/01/2025 | No | Yes |
Additional files
Editorial Notes
16/01/2025: A lay summary of results was uploaded as an additional file.
15/01/2025: The overall study end date has been changed from 16/11/2023 to 29/12/2024 and the plain English summary updated accordingly.
08/11/2023: A contact confirmed the study was up to date.
03/08/2023: The following changes have been made:
1. The recruitment start date has been changed from 01/12/2021 to 01/10/2022.
2. The recruitment end date has been changed from 31/12/2023 to 30/03/2023.
3. The overall study end date has been changed from 29/12/2023 to 16/11/2023 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 29/12/2024 to 16/11/2023.
5. The final enrolment number has been added.
6. The ethics approval has been updated.
27/05/2022: ISRCTN received notification of combined HRA/MHRA approval for this trial on 27/05/2022.
21/02/2022: Trial's existence confirmed by NHS HRA.
