Exertional Oxygen for Interstitial Lung Disease

Overseen By Desi Fuhr, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Disqualifiers: Copd, Cardiovascular disease, Neuromuscular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Exertional Oxygen for Interstitial Lung Disease?

Research shows that using supplemental oxygen during exercise can significantly improve exercise endurance in patients with interstitial lung disease, especially for those with severe lung restriction. This improvement is linked to better oxygen levels in the blood during physical activity. ^{1 2 3 4 5}

Is exertional oxygen safe for humans?

The available research does not specifically address the safety of exertional oxygen, but it is commonly used in conditions like chronic obstructive pulmonary disease (COPD) and interstitial lung disease to help with breathing during physical activity. ^{1 5 6 7 8}

How does the treatment Exertional Oxygen differ from other treatments for interstitial lung disease?

Exertional Oxygen is unique because it involves using supplemental oxygen during physical activity to improve exercise endurance and reduce breathlessness in patients with interstitial lung disease. Unlike other treatments, it specifically targets the drop in oxygen levels that occurs during exertion, helping patients maintain better oxygen saturation and physical performance. ^{1 2 3 4 9}

What is the purpose of 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.

Research Team

Mike Stickland

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for people with a type of lung disease called interstitial lung disease, who have normal oxygen levels while resting but show lower levels during exercise. They should experience a drop in oxygen saturation to between 80-89% when active, as measured by a walking test.

Inclusion Criteria

I have ILD with normal rest oxygen levels but it drops when I'm active.

Exclusion Criteria

Individuals with peripheral vascular disease will be excluded from measurement of vascular function (flow mediated dilation)

I have used oxygen at home for lung disease in the last year.

I have a condition like COPD that might need oxygen therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Collection of baseline physical activity and SpO2, medical history, standard pulmonary function test, and 6-minute walk test

2 weeks

3 visits (in-person)

Treatment

Participants receive 8 weeks of intervention based on randomization: usual care, exertional oxygen, or exertional oxygen plus support

8 weeks

2 visits (in-person)

Washout

2-week washout period to document carry-over effect of intervention

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Exertional Oxygen

Trial Overview The study is testing if using portable oxygen therapy during physical activity over an 8-week period can improve life quality, exercise capacity, ease breathing issues, and benefit blood vessel function in patients. It also examines the impact of support through calls and educational materials.

Participant Groups

Group I: Arm 3 - Exertional Oxygen + Support Experimental Treatment 2 Interventions

8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material

Group II: Arm 2 - Exertional Oxygen Experimental Treatment 1 Intervention

8 weeks of portable oxygen use (from a concentrator) during exertion

Group III: Arm 1 - Usual Care Active Control 1 Intervention

8 weeks of usual care with no supplemental oxygen provided

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Boehringer Ingelheim Collaboration

Collaborator

Trials

2

Recruited

100+

Findings from Research

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]

References

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

Exertional Desaturation and Prescription of Ambulatory Oxygen Therapy in Interstitial Lung Disease. [2020]

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

Effects of walking with a portable oxygen concentrator on muscle oxygenation while performing normal or pursed-lip breathing in patients with interstitial lung disease: a randomized crossover trial. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Exertional hypoxemia is more severe in fibrotic interstitial lung disease than in COPD. [2022]

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

Bicycle endurance performance of patients with interstitial lung disease breathing air and oxygen. [2013]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Safety of exertional desaturation in idiopathic pulmonary fibrosis: An electrocardiography study. [2019]

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

Ambulatory gas usage in patients with chronic obstructive pulmonary disease and exertional hypoxemia. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. [2021]

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

Exertional Oxygen Requirements During Exercise Training in Advanced Interstitial Lung Disease. [2019]