Idiopathic Pulmonary FibrosisHOPE-IPFNCT02551068
High Oxygen Delivery to Preserve Exercise Capacity in Idiopathic Pulmonary Fibrosis Patients Treated With Nintedanib
A study testing 60% Oxygen in people with Idiopathic Pulmonary Fibrosis, run by University of British Columbia at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- 60% Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 8 sitesCanada
- Study dates
- Dec 2015to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
University of Calgary
Calgary, Alberta, T3M1M4
University of Alberta
Edmonton, Alberta, T6G 2R3
McMaster University
Hamilton, Ontario, L8S 4L8
UBC Okanagan
Kelowna, British Columbia, V1V 1V7
Queens University
Kingston, Ontario, K7L 3N6
McGill University
Montreal, Quebec, H3A 0G4
Laval University
Québec, Quebec, G1V 0A6
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- 60% Oxygen, Standard of Care
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60% OxygenOther
While participants are exercising, they will be inhaling 60% oxygen through a mask
Standard of CareOther
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%.
| Study group | Role | What they receive |
|---|---|---|
| 60% Oxgyen | Experimental | While participants are exercising, they will be breathing 60% oxygen through a mask. Receives: Other: 60% Oxygen |
| Standard of Care | Placebo comparator | 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%. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (9)
Change in 6 Minute Walk Distance (6MWD) at 8 weeks
Patients will be asked to walk, at their own pace, as far as they can in 6 minutes.
Measured: 8 weeks
Change in the amount a patient is troubled by their breathlessness at 8 weeks
Measured using the modified Medical Research Council dyspnea scale (mMRC)
Measured: 8 weeks
Change in the amount a patient is troubled by their breathlessness during the 6 Minute Walk Distance test at 8 weeks
Measured using the 10-point Borg scale during 6MWD
Measured: 8 weeks
Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks
Measured using the 10-point Borg scale during cycle exercise tests
Measured: 8 weeks
Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks
Measured using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ).
Measured: 8 weeks
Change in the amount of physical work a patient can do before becoming breathless at 8 weeks
Measured using the oxygen cost diagram (OCD).
Measured: 8 weeks
Patient reported change in amount of physical activity at 8 weeks
Physical activity will be measured using the long form of the international physical activity questionnaire (IPAQ-LF).
Measured: 8 weeks
Change in amount of physical activity at 8 weeks
Physical activity will be measured objectively using the Fit Bit activity monitor.
Measured: 8 weeks
Change in Quality of Life at 8 weeks
Disease-specific quality of life will be measured using the St. George's Respiratory Questionnaire (SGRQ).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2025
- Study completionAug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Chrisopher Ryerson, University of British Columbia
- Investigators
- Chris Ryerson, MD, Principal investigator, St. Paul's HospitalJordan Guenette, PhD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551068
- Sponsor's protocol ID
- H15-01200
- Acronym
- HOPE-IPF
- Status last verified
- May 2026
- First submitted
- 1 Sep 2015
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27348402
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Oxygen Delivery to Preserve Exercise Capacity in IPF Patients Treated With Nintedanib: The HOPE-IPF Study
- ClinicalTrials.gov ID
- NCT02551068
- Acronym / sponsor ID
- HOPE-IPF / H15-01200
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2015
- Primary completion
- Aug 2025 (actual)
- Study completion
- Aug 2025 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60% Oxgyen | Experimental | Other: 60% OxygenWhile participants are exercising, they will be breathing 60% oxygen through a mask. |
| Standard of Care | Placebo comparator | Other: Standard of CareWhile 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%. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60% OxygenWhile participants are exercising, they will be inhaling 60% oxygen through a mask | Other | 60% Oxgyen |
| Standard of CareWhile 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 |
Primary outcome
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.
9 secondary outcomes
Change in 6 Minute Walk Distance (6MWD) at 8 weeks
Time frame: 8 weeks
Change in the amount a patient is troubled by their breathlessness at 8 weeks
Time frame: 8 weeks
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
Change in the amount a patient is troubled by their breathlessness during the cycle exercise test at 8 weeks
Time frame: 8 weeks
Change in how much shortness of breath the patient experiences while doing normal activities at 8 weeks
Time frame: 8 weeks
Change in the amount of physical work a patient can do before becoming breathless at 8 weeks
Time frame: 8 weeks
Patient reported change in amount of physical activity at 8 weeks
Time frame: 8 weeks
Change in amount of physical activity at 8 weeks
Time frame: 8 weeks
Change in Quality of Life at 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 27348402Ryerson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Ryerson, MD principal investigator
St. Paul's Hospital
Jordan Guenette, PhD principal investigator
St. Paul's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60% Oxygen in people with Idiopathic Pulmonary Fibrosis, run by University of British Columbia at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in exercise duration during the constant load exercise test at 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.