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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.
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.