Continuous Versus Demand-Based Oxygen in Patients With Fibrotic Interstitial Lung Disease and Chronic Obstructive Pulmonary Disease (OXYODE)

January 15, 2025 updated by: Sissel Kronborg-White

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sissel Kronborg-White, MD, PhD
  • Phone Number: 004524978716
  • Email: siskro@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Continous oxygen
Oxygen delivery by Continous Oxygen Bottles
Device: Continous Oxygen by Bottles
Oxygen delivery by bottles giving a continous flow.
Other: Demand Based Oxygen
Oxygen Delivery by Demand Oxygen delivery system.
Device: Demand oxygen by Portable Concentrator
Oxygen delivery by consentrators, giving oxygen only when inhaling.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
percentage of saturation <90%
Time Frame: At baseline
Percentage of time when oxygen levels fall below 90% during walk test.
At baseline
minutes of saturation <90%
Time Frame: At baseline
Number of minutes when saturation falls below 90% during walk test.
At baseline
minimum value of oxygen
Time Frame: At baseline
Minimum value of oxygen saturation during walk test
At baseline
Pulse rate
Time Frame: At baseline
Mean pulse rate during walk test
At baseline
Maximum pulse rate
Time Frame: At baseline
Maximum pulse rate during walk test
At baseline
Distance
Time Frame: At baseline
Difference in walk test distance
At baseline
time to recover
Time Frame: At baseline
The time taken to recover oxygen saturation after walk test to the level obtained at rest
At baseline
Patient preference
Time Frame: At baseline
Patient preferences for the two different systems ("Which system do you prefer?"
At baseline
Semi structured qualitative interviews
Time Frame: After 3-6 months
Semi-structured qualitative interviews about patients' view on the different oxygen delivery systems
After 3-6 months
comfort and frequency use oxygen
Time Frame: After 3-6 months
Questions regarding the use of the oxygen delivery systems with respect to comfort and frequency of use
After 3-6 months
Quality of life questionnaire score
Time Frame: After 3-6 months
Change on Quality of life questionnaires between baseline and three to six months
After 3-6 months
Baseline Characteristics
Time Frame: After 3-6 months
Associations between baseline characteristics and effect of and patient views on oxygen delivery systems
After 3-6 months
Maximal Borg scale
Time Frame: At baseline
Maximal rating of dyspnea on the Borg scale (Borg Rating of Percived exertion, range 0-10, where 10 is maximal breathing difficulty).
At baseline
Change Borg scale
Time Frame: At baseline
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)
At baseline
Comfort Likert scale
Time Frame: At baseline
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.
At baseline
Reliability Likert scale
Time Frame: At baseline
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sissel Kronborg-White

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sissel Kronborg-White, MD, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OXYCODE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.

IPD Sharing Time Frame

Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request for up to 5 years after the study has ended.

IPD Sharing Access Criteria

Full access to the protocol, participants dataset and statistical codes will be granted on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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