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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03737409




Registration number
NCT03737409
Ethics application status
Date submitted
18/09/2018
Date registered
9/11/2018
Date last updated
21/11/2024

Titles & IDs
Public title
PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
Scientific title
PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial
Secondary ID [1] 0 0
HREC/18/Alfred/42
Universal Trial Number (UTN)
Trial acronym
PFOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrotic Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ambulatory Oxygen Therapy
Other interventions - Sham Ambulatory Oxygen Therapy

Experimental: Oxygen therapy with POC (AOT group) - 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.

Sham comparator: Sham oxygen therapy with POC (air group) - 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 interventions: Ambulatory Oxygen Therapy
Supplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator

Other interventions: Sham Ambulatory Oxygen Therapy
Air delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in physical activity measured by steps per day
Timepoint [1] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [1] 0 0
Change in functional exercise capacity assessed by 6-minute walk distance
Timepoint [1] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [2] 0 0
Change in health related quality of life evaluated using the St George's Respiratory Questionnaire
Timepoint [2] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [3] 0 0
Change in dyspnea measured using the Dyspnea-12 questionnaire
Timepoint [3] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [4] 0 0
Changes in fatigue evaluated by the Fatigue Severity Scale
Timepoint [4] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [5] 0 0
Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
Timepoint [5] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [6] 0 0
Change in time spent in moderate to vigorous physical activity
Timepoint [6] 0 0
Baseline assessment, 3 month and 6 month assessments
Secondary outcome [7] 0 0
Change in sedentary time
Timepoint [7] 0 0
Baseline assessment, 3 month and 6 month assessments
Secondary outcome [8] 0 0
Skeletal muscle metabolism
Timepoint [8] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [9] 0 0
Systemic inflammation
Timepoint [9] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [10] 0 0
Oxidative stress
Timepoint [10] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [11] 0 0
Use of oxygen therapy
Timepoint [11] 0 0
3 month and 6 month assessments
Secondary outcome [12] 0 0
Oxygen saturation in daily life
Timepoint [12] 0 0
3 month and 6 month assessments
Secondary outcome [13] 0 0
Incremental cost-effectiveness ratio
Timepoint [13] 0 0
6 month assessment

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2024
Sample size
Target
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03737409
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Anne Holland, Professor
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne Holland, Professor
Address 0 0
Country 0 0
Phone 0 0
+61 3 99030214
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03737409