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

NCT ID: NCT02551068

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2026-12-31

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.

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 Unpublished data suggest that breathing 60% oxygen in a pulmonary rehabilitation setting could enable patients to train at higher exercise intensities and thus derive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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

60% Oxgyen

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

Group Type: EXPERIMENTAL

60% Oxygen

Intervention Type: OTHER

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

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%.

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

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%.

Interventions

60% Oxygen

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

Intervention Type: 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%.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Chrisopher Ryerson

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chris Ryerson, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Jordan Guenette, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: COMPLETED

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

UBC Okanagan

Kelowna, British Columbia, Canada

Site Status: COMPLETED

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Queens University

Kingston, Ontario, Canada

Site Status: COMPLETED

McGill University

Montreal, Quebec, Canada

Site Status: COMPLETED

Laval University

Québec, , Canada

Site Status: COMPLETED

Countries

Canada

Central Contacts

Lynda Lazosky

Role: CONTACT

llazosky@btrg.ca

604-682-2344 ext. 64886

Satvir S Dhillon, MSc

Role: CONTACT

satvir.dhillon@hli.ubc.ca

604-806-8835

Facility Contacts

Michael Stickland, PhD

Role: primary

Natya Raghavan, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 27348402 (View on PubMed)

Other Identifiers

H15-01200

Identifier Type: -

Identifier Source: org_study_id