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High Oxygen Delivery for Idiopathic Pulmonary Fibrosis (HOPE-IPF Trial)

N/A

Recruiting

Led By Jordan Guenette, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prescribed nintedanib by their treating physician or currently on nintedanib

6 minute walk distance 50m or more

Must not have

Contraindication to treatment with nintedanib (based on Canadian labeling)

Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial will test if patients with IPF can improve their exercise endurance, breathlessness, and quality of life by breathing 60% oxygen during an 8-week exercise training program.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from wearing an oxygen mask and possible respiratory effects due to high levels of oxygen such as dry or irritated airways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently taking or have been prescribed nintedanib.

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I can walk 50 meters or more in 6 minutes.

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I am 19 years old or older.

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I have been diagnosed with Idiopathic Pulmonary Fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take nintedanib due to health reasons.

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

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I have not taken pirfenidone in the last 4 weeks.

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I have severe emphysema or my breathing test shows severe lung problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in exercise duration during the constant load exercise test at 8 weeks

Secondary study objectives

Change in 6 Minute Walk Distance (6MWD) at 8 weeks

Change in Quality of Life at 8 weeks

Change in amount of physical activity at 8 weeks

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 60% OxgyenExperimental Treatment1 Intervention

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

Group II: Standard of CarePlacebo Group1 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%.

0 / 8Eligibility criteria met