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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT02551068
• Date of registration: 01/09/2015
• Prospective Registration: Yes
• Primary sponsor: University of British Columbia
• Public title: High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib HOPE-IPF
• Scientific title: High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
• Date of first enrolment: December 2015
• Target sample size: 88
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02551068
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Jordan Guenette, PhD
• Affiliation: St. Paul's Hospital

• Name: Chris Ryerson, MD
• Affiliation: St. Paul's Hospital

• Name: Lynda Lazosky

Key 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)



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Other: 60% Oxygen

Other: Standard of Care

Primary Outcome(s)

Change from baseline in exercise duration during the constant load exercise test at 8 weeks [Time Frame: 8 weeks]

Secondary Outcome(s)

Change in the amount of physical work a patient can do before becoming breathless at 8 weeks [Time Frame: 8 weeks]

Change in the amount a patient is troubled by their breathlessness at 8 weeks [Time Frame: 8 weeks]

Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks [Time Frame: 8 weeks]

Patient reported change in amount of physical activity at 8 weeks [Time Frame: 8 weeks]

Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks [Time Frame: 8 weeks]

Change in Quality of Life at 8 weeks [Time Frame: 8 weeks]

Change in 6 Minute Walk Distance (6MWD) at 8 weeks [Time Frame: 8 weeks]

Change in amount of physical activity at 8 weeks [Time Frame: 8 weeks]

Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks [Time Frame: 8 weeks]

Secondary ID(s)

H15-01200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim