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Inhaled Treprostinil for Pulmonary Fibrosis(TETON Trial)
TETON Trial Summary
This trial will study the safety and effectiveness of inhaled treprostinil in people with a lung disease called idiopathic pulmonary fibrosis.
- Idiopathic Pulmonary Fibrosis
- Interstitial Lung Disease
TETON Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
TETON Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2019 Phase 2 & 3 trial • 326 Patients • NCT02630316
Awards & Highlights
TETON Trial Design
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Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
- You have a serious illness that is expected to significantly shorten your lifespan to less than 6 months.The Investigator believes that the subject is able to communicate effectively with study personnel and that they are reliable, willing, and cooperative with the study requirements.People taking pirfenidone or nintedanib must have been on a stable and optimized dose for at least 30 days before the study beginsWomen who might become pregnant during the study must not be pregnant (confirmed by a urine pregnancy test), must not be breastfeeding, and must use two forms of contraception for the duration of the study and for at least 30 days after they stop taking the study drug.If you are male and have a partner who could potentially become pregnant, you must use a condom for the duration of treatment and for at least 48 hours after discontinuing the study drug.You cannot have participated in any experimental treatment or study within the past 30 days, except for observational or registry studies.
- Group 1: Placebo
- Group 2: Inhaled Treprostinil
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there precedent studies on the efficacy of inhaled Treprostinil?
"There are nine active clinical trials related to inhaled treprostinil, four of which are in phase 3. Many of these are based in Little Rock, Arkansas, but there are 234 clinical trial sites for inhaled treprostinil in total."
Are there several sites running this trial in different cities?
"To enroll in this study, patients can visit one of the 72 sites that are currently recruiting. Some of these locations include Baltimore, Stanford and San Francisco. You can select the location nearest you to reduce travel time and inconvenience."
Which medical condition is Inhaled Treprostinil most often used as a treatment for?
"Inhaled Treprostinil is a common medication prescribed to patients with nyha functional class iii pulmonary arterial hypertension. This medication can also help patients that suffer from other conditions like nyha functional class iii, pulmonary arterial hypertension, and who functional class ii-iii pulmonary arterial hypertension."
What makes this trial unique compared to others like it?
"Inhaled Treprostinil has been under scientific scrutiny since 2015. The first clinical trial, which was conducted in 2015 and sponsored by United Therapeutics, involved 70 participants. Following the success of the first Phase 2 trial, Inhaled Treprostinil received drug approval. Today, there are 9 active trials in 101 cities and 6 countries."
Has inhaled Treprostinil received regulatory approval from the FDA?
"Inhaled Treprostinil has received a score of 3 for safety. This is based on the fact that it is a Phase 3 trial, where there is already some evidence of efficacy, as well as multiple rounds of data that support safety."
Are we still looking for more participants for this experiment?
"Yes, this clinical trial is recruiting patients according to the latest information available on clinicaltrials.gov. The listing for this trial was first posted on June 1, 2021 and was most recently updated on November 3, 2022."
How many people are able to join this clinical trial?
"That is accurate. The clinicaltrial.gov website contains information revealing that this trial is actively recruiting patients. The trial was posted on June 1, 2021, and the most recent update was on November 3, 2022. They are looking for a total of 396 patients from 72 different locations."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Average response time
- < 1 Day
Most responsive sites:
- East Carolina University and Leo Jenkins Cancer Center Room 243: < 24 hours
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