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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2022
  • participants needed
    88
  • sponsor
    University of British Columbia
Updated on 24 January 2021
hypertension
dyspnea
nintedanib
pulmonary rehabilitation
idiopathic pulmonary fibrosis
pulse oximetry at rest

Summary

Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. The treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. Due to the fluctuation of the visual field test and re-test measures, the European recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs.

This study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment 60% Oxygen, Standard of Care, Standard of Care
Clinical Study IdentifierNCT02551068
SponsorUniversity of British Columbia
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note