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Title: Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial.
Austin Authors: Holland, Anne E ;Corte, Tamera;Chambers, Daniel C;Palmer, Andrew J;Ekström, Magnus Per;Glaspole, Ian;Goh, Nicole S L ;Hepworth, Graham;Khor, Yet H ;Hoffman, Mariana;Vlahos, Ross;Sköld, Magnus;Dowman, Leona M ;Troy, Lauren K;Prasad, Jyotika D;Walsh, James;McDonald, Christine F 
Affiliation: Department of Respiratory Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Department of Physiotherapy, Alfred Health, Melbourne, Victoria, Australia
Department of Allergy, Immunology and Respiratory Medicine, Monash University, Melbourne, Victoria, Australia
Centre for Health Policy, School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
School of Clinical Medicine, The University of Queensland, Brisbane, Queensland, Australia
Queensland Lung Transplant Service, The Prince Charles Hospital, Brisbane, Queensland, Australia
Faculty of Medicine, University of Melbourne, Melbourne, Victoria, Australia
NHMRC Centre of Research Excellence in Pulmonary Fibrosis, Camperdown, New South Wales, Australia
Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Central Clinical School, The University of Sydney, Sydney, New South Wales, Australia
Institute for Breathing and Sleep
Physiotherapy Department, The Prince Charles Hospital, Brisbane, Queensland, Australia
Department of Allergy, Immunology and Respiratory Medicine, Monash University, Melbourne, Victoria, Australia
Respiratory and Sleep Medicine
School of Health and Biomedical Sciences, RMIT University, Bundoora, Melbourne, Australia
Respiratory Medicine Unit, Department of Medicine Solna and Center for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden
Department of Respiratory Medicine and Allergy, Karolinska University Hospital, Stockholm, Sweden
Statistical Consulting Centre, University of Melbourne, Melbourne, Victoria, Australia
Department of Respiratory and Sleep Medicine, Alfred Health, Melbourne, Victoria, Australia
Health Economics Research Group, Menzies Institute for Medical Research, The University of Tasmania, Hobart, Tasmania, Australia
Respiratory Medicine and Allergology, Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden
Issue Date: 13-Dec-2020 2020-12-13
Publication information: BMJ Open 2020; 10(12): e040798
Abstract: Interstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation. A randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King's Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken. Ethical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences. Registry (NCT03737409).
DOI: 10.1136/bmjopen-2020-040798
ORCID: 0000-0003-2061-845X
PubMed URL: 33318119
Type: Journal Article
Subjects: clinical trials
interstitial lung disease
thoracic medicine
Appears in Collections:Journal articles

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