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Prostacyclin Analogue
Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis (TETON Trial)
Phase 3
Recruiting
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects on pirfenidone or nintedanib must be on a stable and optimized dose for ≥30 days prior to Baseline. Concomitant use of both pirfenidone and nintedanib is not permitted.
Subject is ≥40 years of age, inclusive, at the time of signing informed consent.
Timeline
Screening 3 weeks
Treatment 12 months
Follow Up week 52
Awards & highlights
TETON Trial Summary
This trial will study the safety and effectiveness of inhaled treprostinil in people with a lung disease called idiopathic pulmonary fibrosis.
Who is the study for?
Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) confirmed by HRCT, having an FVC ≥45% predicted. They must not be pregnant or breastfeeding and agree to use contraception. Participants can't have severe obstructive airway disease, recent heart attacks, uncontrolled cardiac disease, or have used certain IPF treatments recently.Check my eligibility
What is being tested?
The trial is testing inhaled treprostinil delivered via a nebulizer against a placebo to see if it improves lung function measured by forced vital capacity (FVC) after one year of treatment in patients with IPF.See study design
What are the potential side effects?
While the side effects for this specific inhalation form are not detailed here, treprostinil can generally cause coughing, headaches, dizziness, nausea, flushing and jaw pain. The severity of these side effects varies from person to person.
TETON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.
Select...
I am 40 years old or older.
Select...
I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.
TETON Trial Timeline
Screening ~ 3 weeks1 visit
Treatment ~ 12 months8 visits
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ 12 months
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Absolute FVC from Baseline to Week 52
Secondary outcome measures
Change in % Predicted FVC from Baseline to Week 52
Change in DLCO from Baseline to Week 52
Change in K-BILD Questionnaire Score from Baseline to Week 52
+3 moreSide effects data
From 2019 Phase 2 & 3 trial • 326 Patients • NCT0263031644%
Cough
28%
Headache
25%
Dyspnoea
18%
Dizziness
15%
Nausea
14%
Fatigue
13%
Diarrhea
12%
Throat irritation
11%
Oropharyngeal pain
9%
Chest pain
8%
Oedema peripheral
7%
Upper respiratory tract infection
6%
N-terminal prohormone brain natriuretic peptide increased
6%
Epistaxis
5%
Chest discomfort
5%
Fall
5%
Rhinorrhoea
4%
Decreased appetite
2%
Acute respiratory failure
2%
Interstitial lung disease
2%
Death
1%
Bronchopulmonary aspergillosis
1%
Chronic respiratory failure
1%
Sepsis
1%
Pulmonary hypertension
1%
Pneumothorax
1%
Chronic obstructive pulmonary disease
1%
Pain in extremity
1%
Bronchitis
1%
Rhinovirus infetion
1%
Cellulitis
1%
Cardiopulmonary failure
1%
Cor pulmonale
1%
Left ventricular failure
1%
Right ventricular failure
1%
Tachycardia
1%
Bradycardia
1%
Influenza
1%
Pneumonia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
B-cell lymphoma
1%
Cerebral haemorrhage
1%
Syncope
1%
Respiratory failure
1%
Combined pulmonary fibrosis and emphysema
1%
Haemoptysis
1%
Hypoxia
1%
Idiopathic pulmonary fibrosis
1%
Acute myocardial infarction
1%
Acute right ventricular failure
1%
Arrythmia
1%
Cardiac arrest
1%
Cardiac failure congestive
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Active Inhaled Treprostinil
TETON Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Inhaled TreprostinilExperimental Treatment2 Interventions
Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose.
Group II: PlaceboPlacebo Group2 Interventions
Matching placebo inhaled using an ultrasonic nebulizer QID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled Treprostinil
2017
Completed Phase 3
~330
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
United TherapeuticsLead Sponsor
107 Previous Clinical Trials
12,811 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
1,383 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.I am not pregnant or breastfeeding and will use two forms of birth control during the study.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.I have been diagnosed with IPF according to the 2018 guidelines and confirmed by a recent HRCT scan.I have taken medication for pulmonary arterial hypertension in the last 60 days.I need more than 10 liters per minute of oxygen to breathe normally when resting.I have not had a heart attack in the last 6 months or unstable chest pain in the last 30 days.I haven't taken part in any medical trials involving treatments in the last 30 days.I haven't taken specific immune system medications recently.I have had a lung clot within the last 3 months.I had a bad reaction or no improvement with a specific heart or lung treatment, leading to its discontinuation.I am 40 years old or older.My doctor expects I have less than 6 months to live due to my lung condition or another illness.I will use a condom during treatment and for 48 hours after stopping the study drug.I have been on a stable dose of either pirfenidone or nintedanib for over 30 days, but not both.I haven't had a worsening of my lung condition or a lung infection in the last 30 days.I am not pregnant or breastfeeding and will use two forms of birth control during the study.I will use a condom during treatment and for 2 days after stopping the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Inhaled Treprostinil
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Idiopathic Pulmonary Fibrosis Patient Testimony for trial: Trial Name: NCT04708782 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
North Carolina
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Pinehurst Medical Clinic, Inc.
LSU Health Science Center Shreveport
National Jewish Health
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
Unable to take OFEV. I am currently using Ofev. i have tried nintedanib but my condition getting worse.
PatientReceived 2+ prior treatments
I have been on Cellcept for a short time and Perfinadone for the last several years. My condition contnues to deteriorate although more slowly.
PatientReceived 2+ prior treatments
My brother, Brian, is dying of IPF and his disease is progressing rapidly so thinking a clinical trial, such as BMP4 or ABT-199 would potentially extend his life and allow him to have a better quality of life.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How soon can we start?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- East Carolina University and Leo Jenkins Cancer Center Room 243: < 24 hours
Average response time
- < 1 Day
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