Testing Hyperoxia against a placebo for interstitial lung disease
Official title: Skeletal Muscle Function in Interstitial Lung Disease
Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease
Interventions
Hyperoxia
Participants breathe 60% oxygen during exercise
Canadian Sites (1)
St. Paul's Hospital
Vancouver, British Columbia, Canada
Eligibility Criteria
See who this study is looking for36 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 40-80 years (inclusive)
- +Age 40-80 (inclusive)
- +Normal pulmonary function (80-120% predicted)
- +A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
- +for ILD Patients:
- +Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- +Appropriate candidate for pulmonary rehabilitation
- +6 minute walk distance 50m or more
- +Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
- +Clinically stable for the preceding 6 weeks
- +Can fluently read and write in English
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Healthy ControlsControl groupThe group a new treatment is measured against.Read more →:
- +No lung or cardiovascular disease
- +Can fluently read and write in English
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for the ILD patients:
- +Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- +Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- +Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- +Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- +Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- +Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)
- +Exclusion Criteria for Healthy Controls:
- +Any medical conditions that prevents them for exercising safely
- +Cardiac pacemaker or any metal or electronic inside the body
- +Currently smoking or previously smoked more than 10 pack-years
Exclusion
- −for the ILD patients:
- −Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- −Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- −Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- −Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- −Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- −Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)
- −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for Healthy ControlsControl groupThe group a new treatment is measured against.Read more →:
- −Any medical conditions that prevents them for exercising safely
- −Cardiac pacemaker or any metal or electronic inside the body
- −Currently smoking or previously smoked more than 10 pack-years
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 investigating how something functions in the body, rather than testing a treatment directly.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Hyperoxia.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 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 40 years to 80 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
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 40 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baselineBaselineYour starting measurements, taken before treatment begins.Read more →) until participants reach volitional exhaustion (assessed for up to 30 minutes).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change in standardized dyspnea score during the constant load exercise test (visit 3) — measured over Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baselineBaselineYour starting measurements, taken before treatment begins.Read more →) until participants reach volitional exhaustion (assessed for up to 30 minutes).
Change in standardized dyspnea score during the constant load exercise test (visit 4) — measured over Dyspnea will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes).
Change in leg muscle strength measured following the constant load exercise test (visit 3) — measured over Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline).
Change in leg muscle strength measured following the constant load exercise test (visit 4) — measured over Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03800017 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 HyperoxiaBiological
Participants breathe 60% oxygen during exercise
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
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 40 years to 80 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?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 40 years to 80 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
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: Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baselineBaselineYour starting measurements, taken before treatment begins.Read more →) until participants reach volitional exhaustion (assessed for up to 30 minutes).
The study as a whole is currently expected to finish around 2026-12-31.
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 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, 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
Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
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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.