60 Participants Needed

Exertional Oxygen for Interstitial Lung Disease

MR
DF
Overseen ByDesi Fuhr, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using portable oxygen during physical activities helps individuals with interstitial lung disease (a lung condition causing scarring) feel better, move more easily, and improve blood vessel function. Participants will receive either portable oxygen, portable oxygen with additional support such as phone calls and educational materials, or continue their usual care without oxygen. The trial suits those with fibrotic interstitial lung disease who maintain normal oxygen levels at rest but experience low oxygen levels during activity. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using oxygen during exercise helps people with interstitial lung disease (ILD) breathe more easily and exercise longer. Studies indicate that this oxygen therapy can improve physical activities by extending exercise duration and reducing shortness of breath.

Regarding safety, most people can use oxygen therapy without major issues. No significant safety concerns have been reported for using oxygen in this manner. Patients should follow equipment instructions and have regular check-ins with healthcare providers to ensure everything proceeds smoothly.12345

Why are researchers excited about this study treatment for interstitial lung disease?

Researchers are excited about exertional oxygen for interstitial lung disease because it offers a promising approach to managing symptoms during physical activity. Unlike the usual care that doesn't include supplemental oxygen, one treatment arm involves using portable oxygen concentrators during exertion, which could improve breathlessness and exercise capacity. Another arm combines this oxygen therapy with additional support from a respiratory educator, providing patients with tailored education and guidance, potentially enhancing the overall quality of life. This dual approach not only targets the physical symptoms but also empowers patients with knowledge, setting it apart from current treatments.

What evidence suggests that exertional oxygen could be an effective treatment for interstitial lung disease?

Research has shown that using portable oxygen during physical activity can help people with interstitial lung disease. In this trial, some participants will receive exertional oxygen, which studies have found allows people to exercise longer and feel less out of breath. Patients report feeling less tired and experiencing a better quality of life when using oxygen while exercising. This treatment improves blood vessel function and makes physical activities easier. Overall, evidence suggests that using oxygen during exercise can effectively assist those who struggle with physical activity due to this condition.12678

Who Is on the Research Team?

MS

Mike Stickland

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3 - Exertional Oxygen + SupportExperimental Treatment2 Interventions
Group II: Arm 2 - Exertional OxygenExperimental Treatment1 Intervention
Group III: Arm 1 - Usual CareActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Comparing the efficacy of exertional oxygen delivery by ...In this trial, we aim to compare various outcomes ... Oxygen in patients with fibrotic interstitial lung disease: an international Delphi survey.
Oxygen therapy for exercise capacity in fibrotic interstitial ...A systematic review and meta-analysis was conducted to evaluate the effectiveness of oxygen therapy in improving the exertional capacity of patients with fILD.
Supplemental Oxygen Therapy in Interstitial Lung DiseaseAvailable evidence suggests that supplemental oxygen in ILD may improve quality of life and some exercise parameters in patients whose hypoxemia is a limiting ...
Oxygen therapy for exercise capacity in fibrotic interstitial ...Oxygen therapy increases exercise duration in patients with fILD. Oxygen therapy reduces fatigue and dyspnea during exercise in patients with fILD.
Oxygen Therapy during Exercise in Patients with Interstitial ...In fact, oxygen supplementation during exercise increased the exercise tolerance and reduced perception of dyspnoea in ILD patients showing ...
Oxygen therapy in COPD and interstitial lung diseaseA systematic review of four randomised placebo-controlled trials of AOT in patients with COPD concluded that oxygen improved exertional dyspnoea ...
A comprehensive review of oxygen therapy in interstitial ...This narrative review examines the critical role of oxygen therapy in ILDs, highlighting its current applications, associated challenges, and emerging ...
Patient-centered Outcomes Research in Interstitial Lung ...Patient-centered outcomes are key to ascertaining whether and how ILD and interventions used to treat it affect the way patients feel and function in their ...
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