PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial

NCT03737409 | Completed DMC

• 1 other identifier: HREC/18/Alfred/42
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The fibrotic interstitial lung diseases (fILD) are characterised by lung scarring, distressing breathlessness and poor health-related quality of life. Exertional desaturation (low blood oxygen during exercise) is a hallmark of fILD, occurring in over 50% of patients. It is sometimes treated with ambulatory oxygen therapy (AOT), which involves breathing supplemental oxygen during physical activity. However the absence of clinical trials has given rise to marked variations in policy and practice globally. Even where AOT is available, treatment adherence using the traditional delivery method of cylinder gas is poor. Recently new devices called portable oxygen concentrators (POCs), have become available, which are lighter and more maneuverable than a cylinder. This may enhance adherence and maximize treatment benefits. This trial will determine the clinical benefits and societal costs of AOT for people with fILD and exertional desaturation. A randomised controlled trial with blinding of participants, assessors and clinicians, and an embedded economic evaluation will be conducted. A total of 260 participants with fILD and exertional desaturation will be randomly assigned to use either AOT or air delivered using a POC for 6 months. If this trial demonstrates clinical and economic benefits of AOT then the findings can be rapidly translated into practice.

Conditions

Fibrotic Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Change in physical activity measured by steps per day

  Steps per day assessed by activity monitors

  Baseline, 3 month and 6 month assessments

Secondary Outcomes (13)

• Change in functional exercise capacity assessed by 6-minute walk distance

  Baseline, 3 month and 6 month assessments

• Change in health related quality of life evaluated using the St George's Respiratory Questionnaire

  Baseline, 3 month and 6 month assessments

• Change in dyspnea measured using the Dyspnea-12 questionnaire

  Baseline, 3 month and 6 month assessments

• Changes in fatigue evaluated by the Fatigue Severity Scale

  Baseline, 3 month and 6 month assessments

• Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale

  Baseline, 3 month and 6 month assessments

Study Arms (2)

Oxygen therapy with POC (AOT group)

EXPERIMENTAL

Patients will receive ambulatory oxygen therapy provided by a portable oxygen concentrator and will be encouraged to use it at all times when they are moving about, including walking at home or in the community, during exercise or during other activities.

Other: Ambulatory Oxygen Therapy

Sham oxygen therapy with POC (air group)

SHAM COMPARATOR

Patients will receive sham ambulatory oxygen therapy provided by a portable oxygen concentrator and will be encouraged to use it at all times when they are moving about, including walking at home or in the community, during exercise or during other activities.

Other: Sham Ambulatory Oxygen Therapy

Interventions

Ambulatory Oxygen Therapy OTHER

Supplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator

Oxygen therapy with POC (AOT group)

Sham Ambulatory Oxygen Therapy OTHER

Air delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air

Sham oxygen therapy with POC (air group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Fibrotic Interstitial Lung Disease
• Stable pharmacotherapy over the last 3 months
• Exertional desaturation (SpO2≤88% for at least 10 consecutive seconds) during a 6 Minute Walking Test performed on room air

You may not qualify if:

• Currently using or eligible for long term oxygen therapy (PaO2≤55 mmHg at rest on room air, or 56-59 mmHg with evidence of right heart failure)
• Current smokers
• Pregnant patients
• Patients cognitively unable to consent; or if death or transplant is anticipated within the study period.
• Participants currently in pulmonary rehabilitation
• Non-ambulant patients
• Admission to an acute care hospital within the last 30 days

Sponsors & Collaborators

• Monash University: lead

Study Sites (1)

Monash University

Melbourne, Victoria, 3004, Australia

Location

Related Publications (3)

• Kawachi S, Hoffman M, Holland AE. Clinical Features Associated With Fatigue in People With Fibrotic Interstitial Lung Disease: Cross-Sectional Study. Respirology. 2025 Nov;30(11):1087-1093. doi: 10.1111/resp.70091. Epub 2025 Jul 20.

  PMID: 40685600 DERIVED

• Hoffman M, Burge AT, Wong N, McDonald CF, Chambers DC, Glaspole I, Mackintosh JA, Ekstrom M, Skold M, Goh NSL, Corte TJ, Holland AE. Exertional Desaturation During the 6-Minute Walk Test vs Daily Life in People With Fibrotic Interstitial Lung Disease. Chest. 2024 Mar;165(3):632-635. doi: 10.1016/j.chest.2023.08.024. Epub 2023 Sep 1. No abstract available.

  PMID: 37659620 DERIVED

• Holland AE, Corte T, Chambers DC, Palmer AJ, Ekstrom MP, Glaspole I, Goh NSL, Hepworth G, Khor YH, Hoffman M, Vlahos R, Skold M, Dowman L, Troy LK, Prasad JD, Walsh J, McDonald CF. Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial. BMJ Open. 2020 Dec 13;10(12):e040798. doi: 10.1136/bmjopen-2020-040798.

  PMID: 33318119 DERIVED

Study Officials

• Anne Holland, Professor

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: November 9, 2018
• Study Start: July 1, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9-36 months after article publication
• Access Criteria: Proposals submitted to corresponding author and approved by Alfred Hospital Human Research Ethics Committee.

Locations

AU (1)