Progressive Pulmonary Fibrosis study: Inhaled Treprostinil
Official title Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
ClinicalTrials.gov ID: NCT05943535
What this study is testing
What is Inhaled Treprostinil?
Inhaled Treprostinil is an investigational medicine, inhaled once daily, being studied as a potential treatment for progressive pulmonary fibrosis.
Also referred to as Tyvaso.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and effective inhaled treprostinil is for treating progressive pulmonary fibrosis over one year.
- Who it's for
- Adults who have progressive pulmonary fibrosis.
- What's involved
- Participants will receive inhaled treprostinil and have regular visits and tests to monitor their condition.
- Time commitment
- The study lasts 52 weeks and includes scheduled visits throughout that period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject gives voluntary informed consent to participate in the study.
- Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
- Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
- Clinically significant decline in % predicted FVC based on ≥10% relative decline
- Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
You likely can't join if
- Subject is pregnant or lactating.
- Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than...
- Subject has a diagnosis of IPF.
- Subject has shown intolerance or significant lack of how well it works to a prostacyclin or prostacyclin analogue that resulted in discontinuation or...
- Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost
- Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
See the full eligibility criteria
- Subject gives voluntary informed consent to participate in the study.
- Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
- Subject has radiological evidence of pulmonary fibrosis of \>10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
- Clinically significant decline in % predicted FVC based on ≥10% relative decline
- Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with worsening of respiratory symptoms
- Marginal decline in % predicted FVC based on ≥5% to \<10% relative decline combined with increasing extent of fibrotic changes on chest imaging
- Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging
- FVC ≥45% predicted at Screening (confirmed by central review).
- On nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, are planning to continue treatment through the study
- Not on treatment with nintedanib or pirfenidone for ≥90 days prior to Baseline and in the Investigator's opinion, not planning to initiate either treatment during the study.
- people treated with immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids, rituximab) need to be on treatment for at least 120 days prior to Baseline and, in the Investigator's...
- Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
- Use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug. i.
- Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending...
- Subject is pregnant or lactating.
- Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC \<0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
- Subject has a diagnosis of IPF.
- Subject has shown intolerance or significant lack of how well it works to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
- Subject has received any PAH-approved therapy, including prostacyclin therapy (epoprostenol, treprostinil, iloprost, or beraprost
- Subject is receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
- Exacerbation of ILD or active pulmonary or upper respiratory infection within 30 days prior to Baseline.
- Subject has uncontrolled cardiac disease, defined as myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline.
- Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to...
- Acute pulmonary embolism within 90 days prior to Baseline.
- In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or would impair study participation or cooperation.
- In the opinion of the Investigator, life expectancy \<12 months due to ILD or a concomitant illness.
- Subject has received nerandomilast within 60 days prior to Baseline.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orange, California, United States
- Redding, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Maywood, Illinois, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
+ 120 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Orange, California, United States; Redding, California, United States and 134 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.