Fibrotic Interstitial Lung DiseasePFOXNCT03737409
PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
A study testing Ambulatory Oxygen Therapy in people with Fibrotic Interstitial Lung Disease, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrotic Interstitial Lung Disease
- What is being tested?
- Ambulatory Oxygen Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2019to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Interstitial lung diseases (ILDs) are characterized by scarring of lung tissue. Stiffening of the lungs leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Around 85% of the ILDs are known as fibrotic ILD (fILD), a form of ILD which tends to have worse outcomes than other types of ILD. People with fibrotic ILD often experience distressing breathlessness, cough and fatigue; loss of independence and life roles; financial strain; and unpleasant treatment side effects.The most common of the fILDs is idiopathic pulmonary fibrosis (IPF), which has an average survival of 3 years from diagnosis. Recently, two new treatments have been shown to halve the annual decline in lung function in mild to moderate IPF, making it a 'treatable' condition for the first time. However, these treatments only slow the decline in lung function; they do not stabilize or reverse it, nor do patients experience improved quality of life or breathlessness.
For people with fILD who have abnormally low oxygen in the blood at rest, long term oxygen therapy (LTOT, used ≥18 hours per day) is strongly recommended, based on survival benefits in studies of people with chronic obstructive pulmonary disease (COPD). However, for people with fILD who have low oxygen levels only during exertion, the role of oxygen therapy is not clear.
Ambulatory oxygen therapy (AOT), defined as the use of oxygen during exercise and activities of daily living, has historically been used to improve blood oxygen levels and exercise capacity. However, many people with fILD find this treatment difficult to use. Oxygen cylinders are heavy and run out quickly, therefore patient burden often exceeds any benefits. Portable oxygen concentrators (POCs) are newly available, lighter and rechargeable. However there are potential disadvantages to POCs. Generally, they deliver oxygen in pulses, which is where oxygen is delivered only when breathing in, and they do not deliver 100% oxygen. Doctors often express concerns that POCs cannot meet the demands of people with fILD during exercise. Recently it was shown that people with fILD who use a POC have similar blood oxygen levels to those who use a cylinder during exercise, suggesting that this might be a useful treatment.
This study will examine the benefits and costs of ambulatory oxygen, delivered using a POC, in people with fILD and exertional desaturation. The aim is to compare the impact of AOT vs air in people with fILD who have low blood oxygen during exercise, and to compare the cost-effectiveness of AOT and air in fILD. A total of 260 people with fILD will be invited to participate. The trial will be conducted at four sites in Australia and two sites in Sweden. Participants will be randomly allocated into two groups; Group 1 will be administered AOT using a POC (AOT group); and Group 2 will be administered sham AOT using an identical POC (air group). Participants, health professionals and trial staff will not be aware of which POC is being used. The allocated treatment will be delivered for 6 months. Measurements of physical activity during daily life, symptoms, exercise capacity and HRQOL will be collected at the beginning of the trial, and 3 and 6 months after treatment has commenced. Information about use of health care services, both from hospital records and directly from participants will also be collected.
- Conditions
- Fibrotic Interstitial Lung Disease
- Being tested
- Ambulatory Oxygen Therapy, Sham Ambulatory Oxygen Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Oxygen TherapyOther
Supplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator
Sham Ambulatory Oxygen TherapyOther
Air delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Ambulatory Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity measured by steps per day
Steps per day assessed by activity monitors
Measured: Baseline, 3 month and 6 month assessments
Secondary outcomes (13)
Change in functional exercise capacity assessed by 6-minute walk distance
Distance in meters achieved on a 6-minute walk test
Measured: Baseline, 3 month and 6 month assessments
Change in health related quality of life evaluated using the St George's Respiratory Questionnaire
St George's Respiratory Questionnaire is a disease-specific health related quality of life questionnaire.The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.
Measured: Baseline, 3 month and 6 month assessments
Change in dyspnea measured using the Dyspnea-12 questionnaire
Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.
Measured: Baseline, 3 month and 6 month assessments
Changes in fatigue evaluated by the Fatigue Severity Scale
Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.
Measured: Baseline, 3 month and 6 month assessments
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.
Measured: Baseline, 3 month and 6 month assessments
Change in time spent in moderate to vigorous physical activity
Time spent in moderate to vigorous physical activity, measured by a wrist-worn, tri-axial accelerometer.
Measured: Baseline assessment, 3 month and 6 month assessments
Change in sedentary time
Time spent sedentary, measured by a wrist-worn, tri-axial accelerometer.
Measured: Baseline assessment, 3 month and 6 month assessments
Skeletal muscle metabolism
Plasma markers of skeletal muscle metabolism (xanthine, hypoxanthine [units pmole/µL]) will be analysed from collected blood samples.
Measured: Baseline, 3 month and 6 month assessments
Systemic inflammation
C-reactive protein [unit ng/mL]) will be analysed from collected blood samples.
Measured: Baseline, 3 month and 6 month assessments
Oxidative stress
Thiobarbituric acid reactive substrates [units µM]) will be analysed from collected blood samples.
Measured: Baseline, 3 month and 6 month assessments
Use of oxygen therapy
Hours of usage of the portable concentrator.
Measured: 3 month and 6 month assessments
Oxygen saturation in daily life
Wrist oximeter that will be worn during waking hours on two consecutive weekdays.
Measured: 3 month and 6 month assessments
Incremental cost-effectiveness ratio
Difference in health care costs compared to differences in quality-adjusted life years -QALYs
Measured: 6 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jul 2019
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne E Holland PhD, FThorSoc, Monash University
- Investigators
- Anne Holland, Professor, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737409
- Sponsor's protocol ID
- HREC/18/Alfred/42
- Acronym
- PFOX
- Status last verified
- Nov 2024
- First submitted
- 18 Sep 2018
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after deidentification of participants after publication, with approval of the Alfred Health Human Research Ethics Committee.
Publications
Hoffman M, Tikellis G, Lee JYT, Wan CS, Khor Y, Goh NS, Glaspole IN, D Prasad J, Smallwood N, McDonald CF, Holland AE. Experiences of using portable oxygen concentrators delivering oxygen or air among people with fibrotic interstitial lung disease in Australia: a qualitative study. BMJ Open. 2026 Sep 21;16(9):e117577. doi: 10.1136/bmjopen-2026-117577.
PubMed 42767727Holland AE, Hoffman M, Corte TJ, Chambers DC, Hepworth G, Ekstrom MP, Glaspole I, Goh NS, Khor YH, Palmer AJ, Barton C, Cox I, Dowman L, Einarsson J, Fuhrmeister L, Mackintosh JA, Neglen P, Prasad JD, Bucciarelli J, Scherp S, Skold M, Smallwood N, Symons K, Thompson M, McDonald CF. Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX): a multicentre, randomised, sham-controlled trial. Lancet Respir Med. 2026 Apr;14(4):317-326. doi: 10.1016/S2213-2600(26)00005-6. Epub 2026 Feb 26.
PubMed 41765033Kawachi 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.
PubMed 40685600Hoffman 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.
PubMed 37659620Holland 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.
PubMed 33318119
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
- ClinicalTrials.gov ID
- NCT03737409
- Acronym / sponsor ID
- PFOX / HREC/18/Alfred/42
- Conditions
- Fibrotic Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interstitial lung diseases (ILDs) are characterized by scarring of lung tissue. Stiffening of the lungs leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Around 85% of the ILDs are known as fibrotic ILD (fILD), a form of ILD which tends to have worse outcomes than other types of ILD. People with fibrotic ILD often experience distressing breathlessness, cough and fatigue; loss of independence and life roles; financial strain; and unpleasant treatment side effects.The most common of the fILDs is idiopathic pulmonary fibrosis (IPF), which has an average survival of 3 years from diagnosis. Recently, two new treatments have been shown to halve the annual decline in lung function in mild to moderate IPF, making it a 'treatable' condition for the first time. However, these treatments only slow the decline in lung function; they do not stabilize or reverse it, nor do patients experience improved quality of life or breathlessness.
For people with fILD who have abnormally low oxygen in the blood at rest, long term oxygen therapy (LTOT, used ≥18 hours per day) is strongly recommended, based on survival benefits in studies of people with chronic obstructive pulmonary disease (COPD). However, for people with fILD who have low oxygen levels only during exertion, the role of oxygen therapy is not clear.
Ambulatory oxygen therapy (AOT), defined as the use of oxygen during exercise and activities of daily living, has historically been used to improve blood oxygen levels and exercise capacity. However, many people with fILD find this treatment difficult to use. Oxygen cylinders are heavy and run out quickly, therefore patient burden often exceeds any benefits. Portable oxygen concentrators (POCs) are newly available, lighter and rechargeable. However there are potential disadvantages to POCs. Generally, they deliver oxygen in pulses, which is where oxygen is delivered only when breathing in, and they do not deliver 100% oxygen. Doctors often express concerns that POCs cannot meet the demands of people with fILD during exercise. Recently it was shown that people with fILD who use a POC have similar blood oxygen levels to those who use a cylinder during exercise, suggesting that this might be a useful treatment.
This study will examine the benefits and costs of ambulatory oxygen, delivered using a POC, in people with fILD and exertional desaturation. The aim is to compare the impact of AOT vs air in people with fILD who have low blood oxygen during exercise, and to compare the cost-effectiveness of AOT and air in fILD. A total of 260 people with fILD will be invited to participate. The trial will be conducted at four sites in Australia and two sites in Sweden. Participants will be randomly allocated into two groups; Group 1 will be administered AOT using a POC (AOT group); and Group 2 will be administered sham AOT using an identical POC (air group). Participants, health professionals and trial staff will not be aware of which POC is being used. The allocated treatment will be delivered for 6 months. Measurements of physical activity during daily life, symptoms, exercise capacity and HRQOL will be collected at the beginning of the trial, and 3 and 6 months after treatment has commenced. Information about use of health care services, both from hospital records and directly from participants will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy with POC (AOT group) | Experimental | Other: Ambulatory Oxygen TherapyPatients 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. |
| Sham oxygen therapy with POC (air group) | Sham comparator | Other: Sham Ambulatory Oxygen TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory Oxygen TherapySupplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator | Other | Oxygen therapy with POC (AOT group) |
| Sham Ambulatory Oxygen TherapyAir delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air | Other | Sham oxygen therapy with POC (air group) |
Primary outcome
Change in physical activity measured by steps per day
Time frame: Baseline, 3 month and 6 month assessments
Steps per day assessed by activity monitors
13 secondary outcomes
Change in functional exercise capacity assessed by 6-minute walk distance
Time frame: Baseline, 3 month and 6 month assessments
Change in health related quality of life evaluated using the St George's Respiratory Questionnaire
Time frame: Baseline, 3 month and 6 month assessments
Change in dyspnea measured using the Dyspnea-12 questionnaire
Time frame: Baseline, 3 month and 6 month assessments
Changes in fatigue evaluated by the Fatigue Severity Scale
Time frame: Baseline, 3 month and 6 month assessments
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Time frame: Baseline, 3 month and 6 month assessments
Change in time spent in moderate to vigorous physical activity
Time frame: Baseline assessment, 3 month and 6 month assessments
Change in sedentary time
Time frame: Baseline assessment, 3 month and 6 month assessments
Skeletal muscle metabolism
Time frame: Baseline, 3 month and 6 month assessments
Systemic inflammation
Time frame: Baseline, 3 month and 6 month assessments
Oxidative stress
Time frame: Baseline, 3 month and 6 month assessments
Use of oxygen therapy
Time frame: 3 month and 6 month assessments
Oxygen saturation in daily life
Time frame: 3 month and 6 month assessments
Incremental cost-effectiveness ratio
Time frame: 6 month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 42767727Hoffman M, Tikellis G, Lee JYT, Wan CS, Khor Y, Goh NS, Glaspole IN, D Prasad J, Smallwood N, McDonald CF, Holland AE. Experiences of using portable oxygen concentrators delivering oxygen or air among people with fibrotic interstitial lung disease in Australia: a qualitative study. BMJ Open. 2026 Sep 21;16(9):e117577. doi: 10.1136/bmjopen-2026-117577.
- Derived from this study: PubMed 41765033Holland AE, Hoffman M, Corte TJ, Chambers DC, Hepworth G, Ekstrom MP, Glaspole I, Goh NS, Khor YH, Palmer AJ, Barton C, Cox I, Dowman L, Einarsson J, Fuhrmeister L, Mackintosh JA, Neglen P, Prasad JD, Bucciarelli J, Scherp S, Skold M, Smallwood N, Symons K, Thompson M, McDonald CF. Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX): a multicentre, randomised, sham-controlled trial. Lancet Respir Med. 2026 Apr;14(4):317-326. doi: 10.1016/S2213-2600(26)00005-6. Epub 2026 Feb 26.
- Derived from this study: PubMed 40685600Kawachi 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.
- Derived from this study: PubMed 37659620Hoffman 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.
- Derived from this study: PubMed 33318119Holland 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.
- Individual participant dataSharing planned: Yes. Data will be available after deidentification of participants after publication, with approval of the Alfred Health Human Research Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Holland, Professor principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Oxygen Therapy in people with Fibrotic Interstitial Lung Disease, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity measured by steps per day (time frame: Baseline, 3 month and 6 month assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03737409, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.