Improving exercise capacity in patients with idiopathic pulmonary fibrosis using high oxygen delivery
High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
This study is testing if breathing 60% oxygen during an exercise program can help people with idiopathic pulmonary fibrosis feel less breathless and improve their ability to exercise while taking nintedanib.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Drugs / interventions | prednisone |
| Locations | 8 sites (Calgary, Alberta and 7 other locations) |
| Trial ID | NCT02551068 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether patients with idiopathic pulmonary fibrosis (IPF) who are treated with nintedanib can enhance their exercise endurance, reduce breathlessness, and improve their quality of life by breathing 60% oxygen during an 8-week pulmonary rehabilitation program. The program includes structured exercise training and education, with participants randomized to either receive standard care or the high oxygen intervention. The study will monitor changes in functional capacity, specifically the 6-minute walk distance, and assess overall clinical benefits. Participants will have multiple visits throughout the study to ensure safety and monitor progress.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 years or older with a confirmed diagnosis of idiopathic pulmonary fibrosis who are stable and prescribed nintedanib.
Not a fit: Patients with contraindications to nintedanib or those with severe pulmonary function impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the exercise capacity and quality of life for patients with idiopathic pulmonary fibrosis.
How similar studies have performed: While the use of high oxygen delivery in pulmonary rehabilitation is promising, this specific approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 19 years or older * Idiopathic Pulmonary Fibrosis (IPF) diagnosis according to American Thoracic Society and/or European Respiratory Society consensus criteria * Appropriate candidate for pulmonary rehabilitation * prescribed nintedanib by their treating physician or currently on nintedanib * 6 minute walk distance 50m or more * Oxygen saturation 92% or more by pulse oximetry at rest while breathing room air * Clinically stable for the preceding 6 weeks Exclusion Criteria: * Contraindication to treatment with nintedanib (based on Canadian labeling) * Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) * Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation * Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25% * Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program * Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit * Use of pirfenidone within 4 weeks of screening * Significant emphysema (less than 10% volume on high resolution computed tomography (HRCT) or forced expiratory volume at one second (FEV1)/FVC less than 0.70)
Where this trial is running
Calgary, Alberta and 7 other locations
- University of Calgary — Calgary, Alberta, Canada (Completed)
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
- UBC Okanagan — Kelowna, British Columbia, Canada (Completed)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
- Queens University — Kingston, Ontario, Canada (Completed)
- McGill University — Montreal, Quebec, Canada (Completed)
- Laval University — Québec, Canada (Completed)
Study contacts
- Principal investigator: Chris Ryerson, MD — St. Paul's Hospital
- Study coordinator: Lynda Lazosky
- Email: llazosky@btrg.ca
- Phone: 604-682-2344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.