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Prostacyclin Analogue

Inhaled Treprostinil for 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
The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy.
FVC ≥45% predicted at Screening.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment 12 months
Follow Upweek 52
Awards & highlights
Pivotal 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.

Eligible Conditions
  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease

TETON Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

TETON Trial Timeline

Screening ~ 3 weeks
Treatment ~ 12 months
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, 12 months for treatment, and week 52 for reporting.

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 more

Side effects data

From 2019 Phase 2 & 3 trial • 326 Patients • NCT02630316
44%
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%
Rhinovirus infetion
1%
Pain in extremity
1%
Bronchitis
1%
Pneumothorax
1%
Sepsis
1%
Pulmonary hypertension
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%
Chronic obstructive pulmonary disease
1%
Chronic respiratory failure
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
12,859 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
1,383 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Inhaled Treprostinil (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT04708782 — Phase 3
Idiopathic Pulmonary Fibrosis Research Study Groups: Placebo, Inhaled Treprostinil
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Inhaled Treprostinil Highlights & Side Effects. Trial Name: NCT04708782 — Phase 3
Inhaled Treprostinil (Prostacyclin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04708782 — Phase 3
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?
18 - 65
65+
What site did they apply to?
David Geffen School of Medicine at UCLA
National Jewish Health
Baylor University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How soon can we start?
PatientReceived 2+ prior treatments

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
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
I have no quality of life anymore my physical ability is limited according to ct scans from last year to this year scaring in my lungs is progressing at the rate that my pulmonologist has ordered another bronchial scope two with in one year.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. East Carolina University and Leo Jenkins Cancer Center Room 243: < 24 hours
~216 spots leftby Jun 2025