Aim

To determine the clinical effectiveness of ambulatory oxygen therapy (AOT) in patients with idiopathic pulmonary fibrosis (IPF).

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Total number participants

The trial will recruit 260 patients with IPF and an MRC dyspnoea score greater than or equal to from centres in the UK.

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Outcome Measures

Primary outcomes:

• Health related quality of life, as measured by the total score on the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire (Reference).

Secondary outcomes:

Clinical Outcomes

• Subscales within K-BILD (breathlessness, activity, chest symptoms)
• Difference of Exercise capacity (6MWT or 1 minute sit to stand) between baseline and six months post randomisation
• Physical activity (international physical activity questionnaire (IPAQ (43)
• Epworth score
• Hospitalisations (all cause and IPF specific)
• VAS for cough
• Targeted adverse events
• Mortality (6 months, and from medical record only at 12 months)
• Medication use: benzodiazepines, antifibrotics; ACEis and opiates for breathlessness).
• Scheduled and unscheduled health service use relating to IPF.
• Completion of pulmonary rehabilitation.

Economic Outcomes

• EQ5D-5L
• Scheduled and unscheduled health service use relating to IPF.

Exploratory Outcomes

• Accelerometry in a subset of 20% of patients)
• Collection of blood samples (Blood gases; FBC/CBC)