RecruitingNot ApplicableNCT02551068

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

Sponsor

University of British Columbia

Enrollment

88 participants

Start Date

Dec 1, 2015

Study Type

INTERVENTIONAL

Conditions

Idiopathic Pulmonary Fibrosis

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria7

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
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 Criteria8

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)

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Interventions

OTHER60% Oxygen

While participants are exercising, they will be inhaling 60% oxygen through a mask

OTHERStandard 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%.