High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib
HOPE-IPF
1 other identifier
interventional
88
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 17, 2025
January 1, 2025
11 years
September 1, 2015
January 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in exercise duration during the constant load exercise test at 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.
8 weeks
Secondary Outcomes (9)
Change in 6 Minute Walk Distance (6MWD) at 8 weeks
8 weeks
Change in the amount a patient is troubled by their breathlessness at 8 weeks
8 weeks
Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks
8 weeks
Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks
8 weeks
Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks
8 weeks
- +4 more secondary outcomes
Study Arms (2)
60% Oxgyen
EXPERIMENTALWhile participants are exercising, they will be breathing 60% oxygen through a mask.
Standard of Care
PLACEBO COMPARATORWhile 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%.
Interventions
While participants are exercising, they will be inhaling 60% oxygen through a mask
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%.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Boehringer Ingelheimcollaborator
Study Sites (8)
University of Calgary
Calgary, Alberta, T3M1M4, Canada
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
UBC Okanagan
Kelowna, British Columbia, V1V 1V7, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
McMaster University
Hamilton, Ontario, L8S 4L8, Canada
Queens University
Kingston, Ontario, K7L 3N6, Canada
McGill University
Montreal, Quebec, H3A 0G4, Canada
Laval University
Québec, G1V 0A6, Canada
Related Publications (1)
Ryerson CJ, Camp PG, Eves ND, Schaeffer M, Syed N, Dhillon S, Jensen D, Maltais F, O'Donnell DE, Raghavan N, Roman M, Stickland MK, Assayag D, Bourbeau J, Dion G, Fell CD, Hambly N, Johannson KA, Kalluri M, Khalil N, Kolb M, Manganas H, Moran-Mendoza O, Provencher S, Ramesh W, Rolf JD, Wilcox PG, Guenette JA. High Oxygen Delivery to Preserve Exercise Capacity in Patients with Idiopathic Pulmonary Fibrosis Treated with Nintedanib. Methodology of the HOPE-IPF Study. Ann Am Thorac Soc. 2016 Sep;13(9):1640-7. doi: 10.1513/AnnalsATS.201604-267OC.
PMID: 27348402DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Ryerson, MD
St. Paul's Hospital
- PRINCIPAL INVESTIGATOR
Jordan Guenette, PhD
St. Paul's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 16, 2015
Study Start
December 1, 2015
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 17, 2025
Record last verified: 2025-01