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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

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%.

Locations (8)

University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
UBC Okanagan
Kelowna, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
McMaster University
Hamilton, Ontario, Canada
Queens University
Kingston, Ontario, Canada
McGill University
Montreal, Quebec, Canada
Laval University
Québec, Canada