Hyperoxia for Interstitial Lung Disease

Recruiting in Palo Alto (17 mi)

Overseen by Jordan A Guenette, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

Must not be taking: Prednisone

Disqualifiers: Cardiovascular, Musculoskeletal, Neurological, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Hyperoxia, Oxygen Therapy, High Oxygen Levels for Interstitial Lung Disease?

Research suggests that while oxygen therapy is often necessary for patients with interstitial lung disease to maintain normal oxygen levels, its effectiveness in improving survival is limited. However, oxygen therapy is crucial for managing symptoms and maintaining quality of life as the disease progresses. ^{1 2 3 4 5}

How does hyperoxia treatment differ from other treatments for interstitial lung disease?

Hyperoxia treatment involves using high levels of supplemental oxygen to help patients with interstitial lung disease exercise more effectively, which is different from standard oxygen therapy that is typically used to manage low oxygen levels at rest or during activity. This approach aims to improve exercise tolerance and enhance pulmonary rehabilitation by allowing patients to train at higher levels. ^{4 6 7 8 9}

Research Team

Jordan A Guenette, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

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.

Participant Groups

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+

Dr. Christopher Haqq

University of British Columbia

Chief Medical Officer since 2019

MD, University of British Columbia

Bekki Bracken Brown

University of British Columbia

Chief Executive Officer since 2023

Bachelor's degree from Duke University

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. England 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? [2023]

2. England pubmed.ncbi.nlm.nih.gov

Domiciliary oxygen for interstitial lung disease. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

The effect of high concentration oxygen therapy on PaCO2 in acute and chronic respiratory disorders. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Acute hemodynamic effects of controlled oxygen therapy in decompensated chronic obstructive pulmonary disease. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of 100 % oxygen during exercise in patients with interstitial lung disease. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Oxygen Therapy for Interstitial Lung Disease. A Mismatch between Patient Expectations and Experiences. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Oxygen for interstitial lung diseases. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of oxygen on sleep and breathing in patients with interstitial lung disease at moderate altitude. [2018]