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

Trial Summary

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 data supports the effectiveness of the treatment 60% Oxygen, Supplemental Oxygen, Oxygen Therapy for Idiopathic Pulmonary Fibrosis?

Some studies suggest that supplemental oxygen can help improve symptoms and quality of life for patients with pulmonary fibrosis by normalizing oxygen levels in the blood. However, the overall survival benefit and long-term effects are not fully understood, and more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is high oxygen delivery safe for humans?

Supplemental oxygen therapy is generally considered safe for managing low oxygen levels in various lung diseases, including idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease. However, it is important to use it correctly and for the prescribed duration to maximize benefits and minimize risks. ^{1 2 6 7 8}

How does high oxygen delivery treatment differ for idiopathic pulmonary fibrosis?

High oxygen delivery treatment for idiopathic pulmonary fibrosis (IPF) is unique because it uses high-flow nasal cannula oxygen therapy (HFNC) to potentially improve exercise capacity, unlike standard oxygen therapy which is typically used to manage low oxygen levels. This approach has been shown to improve oxygenation in other respiratory diseases, but its specific impact on exercise performance in IPF patients is still being evaluated. ^{1 3 5 6 9}

What is the purpose of this trial?

The purpose is to determine if patients with idiopathic pulmonary fibrosis (IPF) taking nintedanib will have improved exercise endurance, breathlessness and quality of life if breathing 60% oxygen compared to standard of care during an 8 week exercise training program.

Research Team

Jordan Guenette, PhD

Principal Investigator

St. Paul's Hospital

Chris Ryerson, MD

Principal Investigator

St. Paul's Hospital

Eligibility Criteria

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.

Your lung function tests show that your breathing capacity is very low.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cohort study to evaluate prognostic factors in idiopathic pulmonary fibrosis patients introduced to oxygen therapy. [2023]

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

Protocol for a mixed-methods study of supplemental oxygen in pulmonary fibrosis. [2021]

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

Titrated oxygen requirement and prognostication in idiopathic pulmonary fibrosis. [2021]

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

Hemodynamic response to low-flow acute supplemental oxygen in idiopathic pulmonary fibrosis and elderly healthy subjects. [2021]

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

Looking ahead and behind at supplemental oxygen: A qualitative study of patients with pulmonary fibrosis. [2022]

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

Oxygen for interstitial lung diseases. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

[Compliance with long-term home oxygen therapy]. [2006]

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

Informal caregivers experience of supplemental oxygen in pulmonary fibrosis. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Impact of high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis: a pilot crossover clinical trial. [2022]