Comparing Exertional Oxygen with Education and Support for fibrotic interstitial lung disease
Official title: Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Interventions
Exertional Oxygen
Use of a portable oxygen concentrator for exertional activities lasting \>2 minutes
Education and Support
Participants will receive disease-specific educational material (Living Well with Pulmonary Fibrosis: Oxygen), and will have scheduled phone appointments with a certified respiratory educator after 1, 3, and 5 weeks of oxygen therapy in order to address individual barriers to oxygen use and facilitate the optimal use of portable oxygen.
Canadian Sites (1)
Clinical Physiology Laboratory
Edmonton, Alberta, Canada
Eligibility Criteria
See who this study is looking for2 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Individuals with fibrotic ILD (all sub-groups of ILD) who have normal oxygen saturation at rest (SpO2 \> 90%) but develop exertional hypoxemia as demonstrated by a SpO2 = 80-89% with activity (measured during 6MWT).
Exclusion
- −Use of home oxygen therapy within the previous year for the management of ILD, co-morbid conditions that may require oxygen therapy (such as COPD, cardiovascular disease, or other illnesses), or individuals that require the use of non-invasive ventilation. Additionally, individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded. Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials and ambulation will also be excluded. Individuals with peripheral vascular disease will be excluded from measurement of vascular function (flow mediated dilation).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Exertional Oxygen, Education and Support.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 85 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around September 2026.
The main measurement is taken over: 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Feasibility of investigation — measured over 2 years.
Exercise tolerance — measured over Before and immediately after the intervention.
Health Related Quality of Life, (EuroQol-5 Dimension-5 Level; EQ-5D-5L) — measured over Before and immediately after the intervention.
Health Related Quality of Life, (King's Brief Interstitial Lung Disease Questionnaire; KBILD) — measured over Before and immediately after the intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06053164 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Exertional OxygenDrug
Use of a portable oxygen concentrator for exertional activities lasting \>2 minutes
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Education and SupportBehavioural
Participants will receive disease-specific educational material (Living Well with Pulmonary Fibrosis: Oxygen), and will have scheduled phone appointments with a certified respiratory educator after 1, 3, and 5 weeks of oxygen therapy in order to address individual barriers to oxygen use and facilitate the optimal use of portable oxygen.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 85 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 85 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 years.
The study as a whole is currently expected to finish around 2026-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.