High Oxygen Delivery for Idiopathic Pulmonary Fibrosis

(HOPE-IPF Trial)

Recruiting at 2 trial locations

Overseen By Satvir S Dhillon, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Nintedanib

Must not be taking: Prednisone, Pirfenidone

Disqualifiers: Cardiovascular, Musculoskeletal, Neurological, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if breathing 60% oxygen (a form of supplemental oxygen therapy) during exercise can reduce breathlessness, improve exercise endurance, and enhance quality of life for people with idiopathic pulmonary fibrosis (IPF). Researchers will compare participants to those receiving standard care, which involves breathing less concentrated oxygen. The trial targets individuals diagnosed with IPF who are stable and already taking the medication nintedanib. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance future treatment options for IPF.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on nintedanib to participate. You cannot have used pirfenidone within 4 weeks of screening or prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit.

What prior data suggests that 60% oxygen is safe for patients with idiopathic pulmonary fibrosis?

Research has shown that oxygen therapy during exercise might benefit people with lung diseases like idiopathic pulmonary fibrosis (IPF). However, clear evidence on its safety remains lacking. Some earlier studies suggested that increased oxygen intake can help patients exercise more intensely, but information on the safety of using 60% oxygen in this context is limited.

While some studies have found that long-term oxygen therapy can increase the risk of death, these studies did not examine short-term use during exercise. Therefore, the safety of oxygen use during exercise sessions remains uncertain. This method is new and under investigation, requiring further research to fully understand its risks and benefits.

Prospective trial participants should consult their healthcare provider to discuss potential benefits and risks based on current evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 60% oxygen delivery for idiopathic pulmonary fibrosis (IPF) because it offers a unique approach to managing the condition. Unlike standard treatments that focus on medications or lung therapies to slow disease progression, this method involves breathing high-concentration oxygen while exercising. This could potentially improve oxygen saturation more effectively during physical activity, which is crucial for patients with IPF. The hope is that this approach can enhance exercise tolerance and overall quality of life for those living with this challenging lung disease.

What evidence suggests that 60% oxygen is effective for idiopathic pulmonary fibrosis?

This trial will compare the effects of high-flow oxygen with standard care during exercise for people with idiopathic pulmonary fibrosis (IPF). Research has shown that high-flow oxygen during exercise can improve exercise capacity in people with IPF. One study found that extra oxygen helps these patients walk farther and feel less breathless during physical activity. About 68% of IPF patients eventually start using oxygen therapy, which is commonly used to manage symptoms. However, long-term oxygen use might carry risks, as some studies suggest a higher risk of death for those who use it continuously. This trial aims to determine if higher oxygen levels can enhance exercise endurance and quality of life during a short-term exercise program. ^{1 4 6 7 8}

Who Is on the Research Team?

Jordan Guenette, PhD

Principal Investigator

St. Paul's Hospital

Chris Ryerson, MD

Principal Investigator

St. Paul's Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 19 with idiopathic pulmonary fibrosis (IPF) who are stable, can walk at least 50 meters in six minutes, and have an oxygen saturation of 92% or higher. They must be on nintedanib treatment and suitable for a lung rehab program. Those with severe lung function loss, recent high-dose steroids use, other significant diseases affecting exercise capacity, or contraindications to nintedanib cannot join.

Inclusion Criteria

My health condition has been stable for the last 6 weeks.

I can walk 50 meters or more in 6 minutes.

Your oxygen level is 92% or higher when you are resting and breathing normal air.

Exclusion Criteria

I have been taking more than 10 mg/day of prednisone for over 2 weeks in the last 3 months.

You have a health condition that makes it unsafe for you to do exercise testing, like heart, muscle, or nerve problems.

You have been in a pulmonary rehabilitation program within the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week exercise training program while receiving either 60% oxygen or standard of care

8 weeks

3 visits per week, plus 13 additional visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 60% Oxygen

Trial Overview The study tests if IPF patients taking nintedanib benefit from breathing 60% oxygen during an eight-week exercise program compared to standard care. It aims to see if the high-oxygen approach improves their ability to exercise, eases breathlessness, and enhances life quality.

How Is the Trial Designed?

Group I: 60% Oxgyen Experimental Treatment 1 Intervention

While participants are exercising, they will be breathing 60% oxygen through a mask.

Group II: Standard of Care Placebo Group 1 Intervention

While participants are exercising, they will be breathing air through a mask that will be titrated to keep oxygen saturation at least 88%, allowing a maximum inhaled oxygen percentage of 40%.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

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]

Long-term home oxygen therapy is beneficial for patients with chronic obstructive pulmonary disease (COPD) and other respiratory conditions, but proper usage and sufficient duration are crucial for maximizing benefits.

The study found that compliance with oxygen therapy was higher in COPD patients compared to those with pulmonary fibrosis or pulmonary hypertension, indicating that the severity of respiratory issues may influence how well patients adhere to their oxygen therapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Compliance with long-term home oxygen therapy]. Hayashi, A., Tatsumi, K., Kato, K., et al.[2006]

In a study of 147 patients with idiopathic pulmonary fibrosis (IPF) starting oxygen therapy, the median survival was approximately 1.5 years, with 76% of patients dying during a median follow-up of 479 days.

Factors such as low body mass index (BMI), low forced vital capacity (FVC), low diffusion capacity (DLCO), and high COPD assessment test (CAT) scores were identified as independent predictors of poor prognosis in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cohort study to evaluate prognostic factors in idiopathic pulmonary fibrosis patients introduced to oxygen therapy. Kataoka, K., Oda, K., Takizawa, H., et al.[2023]

Patients with pulmonary fibrosis generally expect supplemental oxygen to improve their physical function and quality of life, but they often face greater practical and psychological challenges than anticipated after starting its use.

Despite these challenges, patients reported benefits such as improved symptoms, confidence, and mobility, highlighting the need for better guidance and support to help them integrate oxygen therapy into their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Looking ahead and behind at supplemental oxygen: A qualitative study of patients with pulmonary fibrosis. Graney, BA., Wamboldt, FS., Baird, S., et al.[2022]

In a pilot study involving 10 patients with idiopathic pulmonary fibrosis (IPF), high-flow nasal cannula (HFNC) oxygen therapy significantly improved exercise endurance time compared to standard oxygen therapy (SOT), with patients able to exercise for an average of 494 seconds on HFNC versus 381 seconds on SOT.

HFNC also led to a greater increase in inspiratory capacity, suggesting that it may enhance ventilatory mechanics and muscle oxygenation during exercise, although no significant differences in respiratory or leg symptoms were observed between the two therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis: a pilot crossover clinical trial. Badenes-Bonet, D., Cejudo, P., Rodó-Pin, A., et al.[2022]

In a study of 20 patients with idiopathic pulmonary fibrosis (IPF) and 19 healthy controls, IPF patients showed lower stroke volume and cardiac output compared to controls when breathing ambient air, indicating compromised heart function in IPF.

When given low-flow supplemental oxygen, IPF patients experienced a decrease in cardiac output and an increase in total peripheral resistance, suggesting that their hemodynamic response to oxygen differs significantly from healthy individuals, which is important for managing their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic response to low-flow acute supplemental oxygen in idiopathic pulmonary fibrosis and elderly healthy subjects. Santiago-Fuentes, LM., González-Camarena, R., Charleston-Villalobos, S., et al.[2021]

In a study of 104 adults with idiopathic pulmonary fibrosis (IPF), a higher titrated oxygen requirement (TOR) was found to predict increased mortality rates, independent of other measures like lung function tests.

The TOR, which is the lowest oxygen flow rate needed to maintain a saturation of 96%, proved to be as effective as traditional pulmonary function tests in predicting 1-year mortality, making it a valuable and cost-effective tool for assessing patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Titrated oxygen requirement and prognostication in idiopathic pulmonary fibrosis. Hook, JL., Arcasoy, SM., Zemmel, D., et al.[2021]

Informal caregivers (ICs) of patients with pulmonary fibrosis (PF) experience significant emotional and practical challenges when supplemental oxygen therapy is introduced, initially feeling trepidation and sadness about the changes it brings to their loved ones' lives.

Over time, ICs adapt to the presence of oxygen therapy, but it alters their roles, home environments, and relationships, highlighting the need for healthcare providers to offer support and guidance to help mitigate these impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informal caregivers experience of supplemental oxygen in pulmonary fibrosis. Graney, BA., Wamboldt, FS., Baird, S., et al.[2019]

This study will investigate the effects of supplemental oxygen on patients with pulmonary fibrosis by interviewing patients, caregivers, and healthcare providers, and by collecting data from 300 patients over a period of 9-12 months.

The primary focus is to measure changes in dyspnea (difficulty breathing) one month after starting supplemental oxygen, along with secondary outcomes related to cough, fatigue, quality of life, and physical activity, using advanced data collection methods like accelerometers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis. Belkin, A., Fier, K., Albright, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573951/

Impact of high-flow oxygen therapy during exercise in ... Supplemental oxygen delivered with standard oxygen therapy (SOT) improves exercise capacity in patients with idiopathic pulmonary fibrosis (IPF).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02551068

Study Details | NCT02551068 | High Oxygen Delivery to ... The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking nintedanib will have improved exercise endurance, breathlessness and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871663/

Supplemental oxygen therapy use among patients with ... Approximately 68% of patients with IPF and 36% of patients with non-IPF ILD initiated oxygen therapy within 60 months following initial ILD ...

4. 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 ...

5. withpower.com withpower.com/trial/phase-pulmonary-fibrosis-11-2015-5f062

High Oxygen Delivery for Idiopathic Pulmonary Fibrosis In a study of 147 patients with idiopathic pulmonary fibrosis (IPF) starting oxygen therapy, the median survival was approximately 1.5 years, with 76% of ...

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

Oxygen Therapy during Exercise in Patients with Interstitial ... Conclusions: This review showed that the literature on the benefits of oxygen therapy in patients with ILDs does not provide sufficient evidence ...

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

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 ...

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

Supplemental Oxygen Therapy in Interstitial Lung Disease Oxygen use in ILD is rarely included as an outcome in clinical trials. Available evidence suggests that supplemental oxygen in ILD may improve ...