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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02551068
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of British Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chris Ryerson, MDJordan Guenette, PhD
Principal Investigator Affiliation St. Paul's HospitalSt. Paul's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 60% Oxgyen

While participants are exercising, they will be breathing 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%.

Interventions

Other: - 60% Oxygen

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

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%.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Calgary, Calgary, Alberta, Canada

Status

Completed

Address

University of Calgary

Calgary, Alberta, T3M1M4

University of Alberta, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta

Edmonton, Alberta, T6G 2R3

Site Contact

Michael Stickland, PhD

[email protected]

604-682-2344

UBC Okanagan, Kelowna, British Columbia, Canada

Status

Recruiting

Address

UBC Okanagan

Kelowna, British Columbia, V1V 1V7

Site Contact

Neil Eves, PhD

[email protected]

604-682-2344

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

Status

Recruiting

Address

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6

McMaster University, Hamilton, Ontario, Canada

Status

Recruiting

Address

McMaster University

Hamilton, Ontario, L8S 4L8

Site Contact

Natya Raghavan, MD

[email protected]

604-682-2344

Queens University, Kingston, Ontario, Canada

Status

Recruiting

Address

Queens University

Kingston, Ontario, K7L 3N6

Site Contact

Denise O'Donnell, MD

[email protected]

604-682-2344

McGill University, Montreal, Quebec, Canada

Status

Recruiting

Address

McGill University

Montreal, Quebec, H3A 0G4

Site Contact

Jean Bourbeau, MD

[email protected]

604-682-2344

Laval University, Quebec, Canada

Status

Recruiting

Address

Laval University

Quebec, , G1V 0A6

Site Contact

Steve Provencher, MD

[email protected]

604-682-2344

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