Hyperoxia for Interstitial Lung Disease

Overseen By Olivia Ferguson, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Prednisone

Disqualifiers: Cardiovascular, Musculoskeletal, Neurological, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how breathing extra oxygen (known as hyperoxia) might assist people with interstitial lung disease (ILD) during exercise. Researchers aim to determine if leg muscle fatigue contributes to breathlessness and exercise difficulties in ILD patients. Participants will breathe either oxygen-rich air or normal air to compare results. Those with ILD who experience breathlessness or exercise challenges and are stable might be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of ILD and potentially improve exercise tolerance.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit.

What prior data suggests that hyperoxia is safe for ILD patients?

Research shows that using extra oxygen during exercise can benefit people with interstitial lung disease (ILD). Studies have found that it eases exercise and alleviates shortness of breath, a common ILD symptom. These studies do not provide specific information about safety issues related to extra oxygen use. However, oxygen therapy is frequently used for lung diseases, indicating it is generally safe for short-term use, such as during exercise. Consulting a doctor is important to understand the potential risks and benefits for individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperoxia for interstitial lung disease (ILD) because it offers a new approach by enhancing oxygen delivery during exercise. Unlike current treatments that focus on medication to manage symptoms or slow disease progression, hyperoxia involves breathing in a higher concentration of oxygen, specifically 60%, to potentially improve exercise capacity and overall lung function. This method could provide immediate benefits and improve the quality of life for patients by making physical activities less taxing.

What evidence suggests that hyperoxia might be an effective treatment for interstitial lung disease?

Research has shown that using extra oxygen, known as hyperoxia, can benefit people with interstitial lung disease (ILD). In this trial, participants in the hyperoxia arm will breathe supplemental oxygen during exercise. One study found that oxygen therapy during exercise made it easier for ILD patients to be active and improved their symptoms. Another study discovered that oxygen therapy eased shortness of breath when patients were resting. Evidence also suggests that using extra oxygen can enhance quality of life and increase exercise ability for those with low oxygen levels due to ILD. Overall, these findings support the idea that breathing extra oxygen can help reduce symptoms like breathlessness and tiredness in ILD patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Jordan A Guenette, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with certain types of interstitial lung disease (ILD), such as idiopathic pulmonary fibrosis or chronic hypersensitivity pneumonitis. Participants should have some scarring on their lungs, be able to walk at least 50 meters, and have stable oxygen levels without assistance. They must be clinically stable for the last six weeks and capable of undergoing pulmonary rehabilitation.

Inclusion Criteria

I can walk 50 meters or more in 6 minutes.

Can fluently read and write in English

I am between 40 and 80 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Baseline Assessment

Participants complete medical history screening, questionnaires, pulmonary function testing, and an incremental cycle exercise test

1 day

1 visit (in-person)

Muscle Function Assessment

Participants undergo MRI and tests to evaluate quadriceps muscle function

1 day

1 visit (in-person)

Exercise Testing

Participants perform constant-load exercise tests under different oxygen conditions

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in muscle strength and dyspnea scores post-exercise

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperoxia

Trial Overview The study investigates how extra oxygen affects muscle function in ILD patients. It looks at differences in leg muscles between healthy individuals and those with ILD, whether muscle fatigue contributes to breathlessness during exercise, and if breathing extra oxygen can reduce fatigue and improve exercise capacity.

How Is the Trial Designed?

Group I: Hyperoxia Experimental Treatment 1 Intervention

During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise.

Group II: Healthy Controls Placebo Group 1 Intervention

During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

A review of randomized controlled trials found that domiciliary oxygen therapy does not significantly improve survival rates in patients with interstitial lung disease (ILD), as both oxygen-treated and control groups had a similar mortality rate of about 91% after 3 years.

The single trial identified did not report on the effects of oxygen therapy on quality of life or physiological parameters, indicating a lack of comprehensive data on the benefits of this treatment for ILD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domiciliary oxygen for interstitial lung disease. Crockett, AJ., Cranston, JM., Antic, N.[2021]

In a study of 22 patients with decompensated COPD, controlled oxygen therapy at lower fractions (FIO2 0.24 and 0.28) significantly improved blood oxygen levels without greatly increasing carbon dioxide levels, but did not enhance oxygen delivery to tissues.

Higher oxygen fractions (FIO2 0.35 and 0.40) further improved oxygenation and tissue delivery but caused a significant increase in carbon dioxide levels, indicating that while oxygen therapy can enhance blood oxygenation, it may not effectively dilate pulmonary blood vessels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of controlled oxygen therapy in decompensated chronic obstructive pulmonary disease. Lejeune, P., Mols, P., Naeije, R., et al.[2019]

Supplemental oxygen (O2) is often necessary for patients with fibrosing interstitial lung disease (fILD) as their condition progresses, impacting their quality of life significantly.

Despite the potential benefits of O2 therapy, patients frequently experience frustration and fear regarding its use, highlighting the need for 'O2 need' to be considered as a key patient-centered endpoint in therapeutic trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to include oxygen needs as an endpoint in clinical trials in patients with fibrosing interstitial lung disease? If so, how? Aronson, K., Jacobs, SS., Repola, D., et al.[2023]

In a study of 240 patients starting long-term domiciliary oxygen therapy for chronic hypoxia, those with tuberculosis had a better survival prognosis compared to those with interstitial fibrosis, indicating that the underlying cause of hypoxia significantly impacts long-term outcomes.

Key predictors of survival included performance status, arterial carbon dioxide tension (PaCO2), and lung function measurements like forced vital capacity (FVC), with lower values associated with increased mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term oxygen therapy in parenchymal lung diseases: an analysis of survival. The Swedish Society of Chest Medicine. Ström, K., Boman, G.[2016]

A qualitative study involving 24 adults with interstitial lung disease revealed that patients using domiciliary oxygen therapy had varied experiences and expectations, with oxygen-naive patients primarily hoping for relief from breathlessness, while oxygen-experienced patients recognized broader benefits beyond just dyspnea relief.

Both groups identified practical and psychosocial challenges associated with oxygen therapy, highlighting the need for healthcare providers to address these concerns to improve patient adherence and satisfaction with treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen Therapy for Interstitial Lung Disease. A Mismatch between Patient Expectations and Experiences. Khor, YH., Goh, NSL., McDonald, CF., et al.[2022]

High concentration oxygen therapy can increase carbon dioxide levels (PaCO2) not only in COPD but also in other respiratory disorders like asthma and pneumonia, as well as chronic conditions like obesity hypoventilation syndrome.

Consensus guidelines recommend careful titration of oxygen therapy in these conditions to maximize benefits while minimizing the risks associated with excessive oxygen (hyperoxia).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of high concentration oxygen therapy on PaCO2 in acute and chronic respiratory disorders. Pilcher, J., Perrin, K., Beasley, R.[2020]

In a study of 6 patients with interstitial lung disease (ILD), breathing pure oxygen during exercise did not significantly increase exercise time or ventilatory response compared to breathing air, suggesting that hyperoxia may alter the body's response to exercise.

Despite the lack of increased exercise time, hyperoxia could allow patients with ILD to train at higher workloads more efficiently, potentially leading to improved outcomes in pulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 100 % oxygen during exercise in patients with interstitial lung disease. Cournoyer, J., Ramos, CF., Sturgill, B., et al.[2021]

Supplemental oxygen significantly improved oxygen saturation levels in patients with interstitial lung disease (ILD) during sleep, increasing from an average of 82.3% to 94.8%, which is crucial for their respiratory health.

While oxygen therapy reduced breathing frequency and heart rate in ILD patients, it did not improve sleep efficiency or arousal index compared to controls, indicating that while oxygen helps with hypoxia, it does not fully normalize breathing patterns during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of oxygen on sleep and breathing in patients with interstitial lung disease at moderate altitude. Vázquez, JC., Pérez-Padilla, R.[2018]

Supplemental oxygen therapy is recommended for patients with interstitial lung disease (ILD) to manage resting hypoxaemia, and it may improve symptoms and quality of life during daily activities.

While long-term oxygen therapy is standard for resting hypoxaemia, the benefits of supplemental oxygen during exercise training are promising, and ongoing trials aim to further evaluate its effectiveness for exertional hypoxaemia and nocturnal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen for interstitial lung diseases. Khor, YH., Smith, DJF., Johannson, KA., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772632024000552

A comprehensive review of oxygen therapy in interstitial ... Oxygen therapy is crucial in ILD management, offering benefits beyond hypoxemia correction, including symptom relief and potential influence on disease ...

2. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.202304-391CME

Supplemental Oxygen Therapy in Interstitial Lung Disease Available evidence suggests that supplemental oxygen in ILD may improve quality of life and some exercise parameters in patients whose hypoxemia is a limiting ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9138856/

Oxygen Therapy during Exercise in Patients with Interstitial ... A 2018 study called AmbOx provided important data on the effects of oxygen therapy during daily activities, showing significant improvements in ...

4. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-025-03139-3

Supplemental oxygen therapy use among patients with ... In this study, nearly 40% of fibrosing ILD patients had evidence of oxygen therapy within the first 5 years following their ILD diagnosis. The ...

5. publications.ersnet.org publications.ersnet.org/content/errev/26/143/160080

Oxygen therapy for interstitial lung disease: a systematic review One study showed reduction in dyspnoea at rest with oxygen in patients who were acutely unwell (MD visual analogue scale 30 mm versus 48 mm, p<0.05; n=10). Four ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6745413/

Oxygen therapy in COPD and interstitial lung disease The observed high mortality rates are consistent with findings from retrospective studies of patients with ILD who were on LTOT, showing 50% of ...

7. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/12/1/e003153

Use of supplemental oxygen therapy in idiopathic ... Patients exposed to LTOT had a significantly higher risk of death compared with those who were not (HR: 2.9 (95% CI: 2.8 to 3.0) among those ...