NCT02551068

High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib

High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Pulmonary rehabilitation is a structured evidence-based exercise and education intervention that is recommended for most patients with IPF. Pulmonary rehabilitation improves functional capacity (6-minute walk distance \[6MWD\]), breathlessness and quality of life in patients, however these benefits are often modest and only temporary. Nintedanib is an antifibrotic medication that has been shown to slow the decline of lung function. Use of antifibrotic medications in the pulmonary rehabilitation setting may therefore allow prolonged benefit of exercise training by preventing IPF progression and the resulting worsening symptoms and functional decline. Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive greater physiological adaptations and clinical benefits compared with traditional pulmonary rehabilitation. This is a randomized, blinded study with two arms (standard of care or 60% oxygen). The decision to start or stop treatment with nintedanib will be made by the participants treating physician based on clinical findings. If the treating physician decides to discontinue nintedanib, the participant will be allowed to continue in the study. The exercise training program is 8 weeks long, with visits 3 times a week. In addition to the exercise training there are 13 visits occurring before, during and after the 8 week exercise training program. At study visits, participants will be required to conduct a 6 minute walk test and complete a quality of life questionnaire. Select study visits will also require lung function tests and exercise tests to be conducted.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
OTHER	60% Oxygen	While participants are exercising, they will be inhaling 60% oxygen through a mask
OTHER	Standard of Care	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%.

Timeline

• Start date: 2015-12-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2015-09-16
• Last updated: 2025-01-17

Locations

8 sites across 1 country: Canada