Interstitial Lung DiseaseOXYODENCT06767904
Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease
A study testing Continous Oxygen by Bottles and Demand oxygen by Portable Concentrator in people with Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease, run by Sissel Kronborg-White.
Trial summary
The goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Continous Oxygen by Bottles and Demand oxygen by Portable Concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease
- Desaturation < 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen
- Able to walk at least 50 meters during a 6-minute walk test
- Self-reported stable respiratory symptoms in the previous 2 weeks
- Cognitively able to understand and participate in the study
- Written informed consent
Who cannot join
- Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance
- Unstable heart condition or symptomatic stenotic valve disease
- Smoking during the previous 24 hours
- Pregnant women
- Anemia, Hb < 7.3 mmol/l (women) or < 8.3 mmol/l (men)
- Non-invasive ventilation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Protocol for a Randomized Trial Comparing the Efficacy of Exertional Oxygen Delivery by Continuous Versus Demand-Based Flow Systems During Six-minute Walk Test in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYCODE)
The goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . The main questions it aim to answer:
Is there a difference in lowest oxygen saturation? Is there a difference in saturation: time below <90%, pulse rate, distance and patient preferences ? It is a cross over study, so all patients will test both methods. Participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.
Read the detailed description
The study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with chronic obstructive Pulmonary disease or fibrotic Interstitial Lung Disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. The participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. Primary endpoint is the difference in the lowest oxygen saturation between the two systems. Secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. After 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy.
- Being tested
- Continous Oxygen by Bottles, Demand oxygen by Portable Concentrator
- Keywords
- Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Oxygen Therapy, Palliation
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Oxygen by BottlesDevice
Oxygen delivery by bottles giving a continous flow.
Demand oxygen by Portable ConcentratorDevice
Oxygen delivery by consentrators, giving oxygen only when inhaling.
| Study group | Role | What they receive |
|---|---|---|
| Continous oxygen | Other | Oxygen delivery by Continous Oxygen Bottles Receives: Device: Continous Oxygen by Bottles |
| Demand Based Oxygen | Other | Oxygen Delivery by Demand Oxygen delivery system. Receives: Device: Demand oxygen by Portable Concentrator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest oxygen
difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.
Measured: At Baseline
Secondary outcomes (16)
percentage of saturation <90%
Percentage of time when oxygen levels fall below 90% during walk test.
Measured: At baseline
minutes of saturation <90%
Number of minutes when saturation falls below 90% during walk test.
Measured: At baseline
minimum value of oxygen
Minimum value of oxygen saturation during walk test
Measured: At baseline
Pulse rate
Mean pulse rate during walk test
Measured: At baseline
Maximum pulse rate
Maximum pulse rate during walk test
Measured: At baseline
Distance
Difference in walk test distance
Measured: At baseline
time to recover
The time taken to recover oxygen saturation after walk test to the level obtained at rest
Measured: At baseline
Maximal Borg scale
Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty).
Measured: At baseline
Change Borg scale
Change in dyspnea from rest to end of the walk test measured by the Borg scale. (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty)
Measured: At baseline
Patient preference
Patient preferences for the two different systems ("Which system do you prefer?"
Measured: At baseline
Comfort Likert scale
Comfort measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.
Measured: At baseline
Reliability Likert scale
Reliability measured by a Likert scale on a scale from 1-7 where 1 equals strongly disagree and 7 equals strongly agree. There is no unabbreviated scale title.
Measured: At baseline
Semi structured qualitative interviews
Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems
Measured: After 3-6 months
comfort and frequency use oxygen
Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use
Measured: After 3-6 months
Quality of life questionnaire score
Change on Quality of life questionnaires between baseline and three to six months
Measured: After 3-6 months
Baseline Characteristics
Associations between baseline characteristics and effect of and patient views on oxygen delivery systems
Measured: After 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sissel Kronborg-White
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sissel Kronborg-White, Aarhus University Hospital
- Investigators
- Sissel Kronborg-White, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767904
- Sponsor's protocol ID
- OXYCODE
- Acronym
- OXYODE
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.
Publications
Kronborg-White S, Jensen JH, Bendstrup E, Prior TS. Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial. BMJ Open. 2025 May 16;15(5):e099664. doi: 10.1136/bmjopen-2025-099664.
PubMed 40379312
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protocol for a Randomized Trial Comparing the Efficacy of Exertional Oxygen Delivery by Continuous Versus Demand-Based Flow Systems During Six-minute Walk Test in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYCODE)
- ClinicalTrials.gov ID
- NCT06767904
- Acronym / sponsor ID
- OXYODE / OXYCODE
- Keywords
- Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Oxygen Therapy, Palliation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sissel Kronborg-WhiteUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Jan 2025 (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 goal of this randomised clinical trial is to compare the efficacy of exertional oxygen delivery by continous versus demand-based flow systems in patients with fibrotic Interstitial lung disease and chronic obstructive pulmonary disease . The main questions it aim to answer:
Is there a difference in lowest oxygen saturation? Is there a difference in saturation: time below <90%, pulse rate, distance and patient preferences ? It is a cross over study, so all patients will test both methods. Participants will perform 2 6-minute walk tests with the two different oxygen delivery systems.
Detailed description
The study design is a single center, randomized, open-label cross-over exploratory comparative study to investigate the efficacy of two different oxygen delivery systems. Patients with chronic obstructive Pulmonary disease or fibrotic Interstitial Lung Disease that during a six-minute walk test can walk at least 50 m and desaturate below 88%, can be included in the study. The participants are performing 2 6-minute walk tests, randomized to perform the test with oxygen bottles or portable concentrators first. Primary endpoint is the difference in the lowest oxygen saturation between the two systems. Secondary endpoints are amongst others: difference in percentage of time and number of minutes when oxygen falls below 90%, mean and maximum pulse rate, distance and time taken to recover during the 6-minute walk test and scores from questionnaires. After 3-6 months, semistructured interviews will be done to record participants' experiences of ambulatory oxygen therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous oxygen | Other | Device: Continous Oxygen by BottlesOxygen delivery by Continous Oxygen Bottles |
| Demand Based Oxygen | Other | Device: Demand oxygen by Portable ConcentratorOxygen Delivery by Demand Oxygen delivery system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Verified diagnosis of fibrotic interstitial lung disease or chronic obstructive pulmonary disease
- Desaturation < 88% during 6-minute walk test or currently receiving ambulatory oxygen by continous oxygen
- Able to walk at least 50 meters during a 6-minute walk test
- Self-reported stable respiratory symptoms in the previous 2 weeks
Key exclusion criteria (6 listed)
- Any physical condition including paralysis, lower extremity pain, or other musculoskeletal problems limiting exercise performance
- Unstable heart condition or symptomatic stenotic valve disease
- Smoking during the previous 24 hours
- Pregnant women
- Anemia, Hb < 7.3 mmol/l (women) or < 8.3 mmol/l (men)
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 |
|---|---|---|
| Continous Oxygen by BottlesOxygen delivery by bottles giving a continous flow. | Device | Continous oxygen |
| Demand oxygen by Portable ConcentratorOxygen delivery by consentrators, giving oxygen only when inhaling. | Device | Demand Based Oxygen |
Primary outcome
Lowest oxygen
Time frame: At Baseline
difference in the lowest oxygen saturation between the two different oxygen delivery systems during a 6-min. walk test.
16 secondary outcomes
percentage of saturation <90%
Time frame: At baseline
minutes of saturation <90%
Time frame: At baseline
minimum value of oxygen
Time frame: At baseline
Pulse rate
Time frame: At baseline
Maximum pulse rate
Time frame: At baseline
Distance
Time frame: At baseline
time to recover
Time frame: At baseline
Maximal Borg scale
Time frame: At baseline
Change Borg scale
Time frame: At baseline
Patient preference
Time frame: At baseline
Comfort Likert scale
Time frame: At baseline
Reliability Likert scale
Time frame: At baseline
Semi structured qualitative interviews
Time frame: After 3-6 months
comfort and frequency use oxygen
Time frame: After 3-6 months
Quality of life questionnaire score
Time frame: After 3-6 months
Baseline Characteristics
Time frame: After 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 40379312Kronborg-White S, Jensen JH, Bendstrup E, Prior TS. Comparing the efficacy of exertional oxygen delivery by continuous versus demand-based flow systems during 6-minute walk test in patients with fibrotic interstitial lung disease and COPD in a hospital setting (OXYCODE): a protocol for a randomised trial. BMJ Open. 2025 May 16;15(5):e099664. doi: 10.1136/bmjopen-2025-099664.
- Individual participant dataSharing planned: Yes. Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.
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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.
Sissel Kronborg-White, MD, PhD principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Continous Oxygen by Bottles and Demand oxygen by Portable Concentrator in people with Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease, run by Sissel Kronborg-White.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sissel Kronborg-White, MD, PhD (004524978716, siskro@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest oxygen (time frame: At Baseline). 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 NCT06767904, which also lists 1 linked publication.
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 17 Jan 2025.