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?

Ambulatory oxygen for idiopathic pulmonary fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16366011

Enrollment

260

Registered

2022-05-27

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis (IPF) Respiratory Idiopathic Pulmonary Fibrosis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
The King's Brief Interstitial Lung Disease (K-BILD) score at baseline and 6 months	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026