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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
Awards & highlights
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 belowSelect...
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:Select...
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.
Select...
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
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 moreTrial 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%.
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Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,534 Previous Clinical Trials
11,357,439 Total Patients Enrolled
50 Trials studying Idiopathic Pulmonary Fibrosis
47,093 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,102 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
40 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Jordan Guenette, PhDPrincipal InvestigatorSt. Paul's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My health condition has been stable for the last 6 weeks.I have been taking more than 10 mg/day of prednisone for over 2 weeks in the last 3 months.I can walk 50 meters or more in 6 minutes.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.You have been in a pulmonary rehabilitation program within the past 6 months.Your oxygen level is 92% or higher when you are resting and breathing normal air.I cannot take nintedanib due to health reasons.I have a health condition besides lung disease that affects my ability to exercise or breathe.I have not taken pirfenidone in the last 4 weeks.I have severe emphysema or my breathing test shows severe lung problem.I am currently taking or have been prescribed nintedanib.I am a good candidate for lung rehab.I am 19 years old or older.I have been diagnosed with Idiopathic Pulmonary Fibrosis.
Research Study Groups:
This trial has the following groups:- Group 1: 60% Oxgyen
- Group 2: Standard of Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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