TETON study: A randomized, double-blind, placebo-controlled, study of the efficacy and safety of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis
The purpose of this research study is to see how well inhaled treprostinil works in participants with IPF and to gather information on how effective and safe it is. This study will look at changes in patient breathing tests, also called lung function tests.
About the study
Principal investigator
Dr. Chris Ryerson
Professor
Area(s) of medical focus
Breathing & Lung
Condition(s)
Interstitial lung disease
Period of enrollment
2024-02-01 - 2025-04-30
Participating sites
St. Paul's Hospital
Purpose of trial
Study RIN-PF-301 is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.
Eligibility
To be eligible to participate:
- The type of IPF you have must be appropriate for this study.
- Your lung function test must meet the relevant criteria.
- If you take pirfenidone or nintedanib your dose cannot change within 30 days of the Baseline visit.
- You can’t take both pirfenidone and nintedanib in this study.
- If you can become pregnant you must have a negative pregnancy test at the screening and baseline visits and agree to not become pregnant during the study.
