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High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib (HOPE-IPF)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by University of British Columbia
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT02551068
First received: September 1, 2015
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Idiopathic Pulmonary Fibrosis Other: 60% Oxygen Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change from baseline in exercise duration during the constant load exercise test at 8 weeks [ Time Frame: 8 weeks ]
    An constant load exercise test on a stationary bike will be performed. Patients will be told to exercise for as long as possible and endurance time will be defined as the duration of the constant load exercise test.


Secondary Outcome Measures:
  • Change in 6 Minute Walk Distance (6MWD) at 8 weeks [ Time Frame: 8 weeks ]
    Patients will be asked to walk, at their own pace, as far as they can in 6 minutes.

  • Change in the amount a patient is troubled by their breathlessness at 8 weeks [ Time Frame: 8 weeks ]
    Measured using the modified Medical Research Council dyspnea scale (mMRC)

  • 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 ]
    Measured using the 10-point Borg scale during 6MWD

  • Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks [ Time Frame: 8 weeks ]
    Measured using the 10-point Borg scale during cycle exercise tests

  • Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks [ Time Frame: 8 weeks ]
    Measured using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ).

  • Change in the amount of physical work a patient can do before becoming breathless at 8 weeks [ Time Frame: 8 weeks ]
    Measured using the oxygen cost diagram (OCD).

  • Patient reported change in amount of physical activity at 8 weeks [ Time Frame: 8 weeks ]
    Physical activity will be measured using the long form of the international physical activity questionnaire (IPAQ-LF).

  • Change in amount of physical activity at 8 weeks [ Time Frame: 8 weeks ]
    Physical activity will be measured objectively using the Fit Bit activity monitor.

  • Change in Quality of Life at 8 weeks [ Time Frame: 8 weeks ]
    Disease-specific quality of life will be measured using the St. George's Respiratory Questionnaire (SGRQ).


Estimated Enrollment: 88
Study Start Date: December 2015
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 60% Oxgyen
While participants are exercising, they will be breathing 60% oxygen through a mask.
Other: 60% Oxygen
While participants are exercising, they will be inhaling 60% oxygen through a mask
Placebo Comparator: 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%.
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%.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02551068

Contacts
Contact: Lynda Lazosky 604-682-2344 ext 64888 llazosky@providencehealth.bc.ca
Contact: Alicia Murdoch 604-682-2344 ext 64886 amurdoch@providencehealth.bc.ca

Locations
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T3M1M4
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Michael Stickland, PhD         
Canada, British Columbia
UBC Okanagan Recruiting
Kelowna, British Columbia, Canada, V1V 1V7
Contact: Neil Eves, PhD         
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L8S 4L8
Queens University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Contact: Denise O'Donnell, MD         
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H3A 0G4
Contact: Jean Bourbeau, MD         
Laval University Recruiting
Quebec City, Quebec, Canada, G1V 0A6
Contact: Steve Provencher, MD         
Sponsors and Collaborators
University of British Columbia
Boehringer Ingelheim
Investigators
Principal Investigator: Chris Ryerson, MD St. Paul's Hospital
Principal Investigator: Jordan Guenette, PhD St. Paul's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02551068     History of Changes
Other Study ID Numbers: H15-01200
Study First Received: September 1, 2015
Last Updated: May 15, 2017

Additional relevant MeSH terms:
Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017