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

Idiopathic Pulmonary Fibrosis

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    19 and up

Participation 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)

Study Location

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

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Primary Contact

Michael Stickland, PhD

Queens University
Queens University
Kingston, Ontario
Canada

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University of Calgary
University of Calgary
Calgary, Alberta
Canada

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McMaster University
McMaster University
Hamilton, Ontario
Canada

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Primary Contact

Natya Raghavan, MD

UBC Okanagan
UBC Okanagan
Kelowna, British Columbia
Canada

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McGill University
McGill University
Montreal, Quebec
Canada

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St. Paul's Hospital
St. Paul's Hospital
Vancouver, British Columbia
Canada

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Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT02551068