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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03737409
Ethics application status
Date submitted
18/09/2018
Date registered
9/11/2018
Date last updated
19/12/2019

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 - Steps per day assessed by activity monitors
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 - Distance in meters achieved on a 6-minute walk test
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - Time spent in moderate to vigorous physical activity, measured by a wrist-worn, tri-axial accelerometer.
Timepoint [6] 0 0
Baseline assessment, 3 month and 6 month assessments
Secondary outcome [7] 0 0
Change in sedentary time - Time spent sedentary, measured by a wrist-worn, tri-axial accelerometer.
Timepoint [7] 0 0
Baseline assessment, 3 month and 6 month assessments
Secondary outcome [8] 0 0
Skeletal muscle metabolism - Plasma markers of skeletal muscle metabolism (xanthine, hypoxanthine [units pmole/µL]) will be analysed from collected blood samples.
Timepoint [8] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [9] 0 0
Systemic inflammation - C-reactive protein [unit ng/mL]) will be analysed from collected blood samples.
Timepoint [9] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [10] 0 0
Oxidative stress - Thiobarbituric acid reactive substrates [units µM]) will be analysed from collected blood samples.
Timepoint [10] 0 0
Baseline, 3 month and 6 month assessments
Secondary outcome [11] 0 0
Use of oxygen therapy - Hours of usage of the portable concentrator.
Timepoint [11] 0 0
3 month and 6 month assessments
Secondary outcome [12] 0 0
Oxygen saturation in daily life - Wrist oximeter that will be worn during waking hours on two consecutive weekdays.
Timepoint [12] 0 0
3 month and 6 month assessments
Secondary outcome [13] 0 0
Incremental cost-effectiveness ratio - Difference in health care costs compared to differences in quality-adjusted life years -QALYs
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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT03737409
Trial related presentations / publications
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
anne.holland@monash.edu
Contact person for scientific queries

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