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Prostacyclin Analogue

Inhaled Treprostinil for Pulmonary Fibrosis (TETON-OLE Trial)

Phase 3
Waitlist Available
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 years
Awards & highlights

TETON-OLE Trial Summary

This trial is looking at the long-term effects of a medication called treprostinil in people with idiopathic pulmonary fibrosis.

Who is the study for?
This trial is for adults with idiopathic pulmonary fibrosis who previously participated in related studies (RIN-PF-301 or RIN-PF-303) and completed them or were active when the study ended. Participants must use effective contraception if of childbearing potential, be non-pregnant, non-lactating, reliable, and able to follow the study plan.Check my eligibility
What is being tested?
The focus of this extension study is on assessing the long-term safety and tolerability of an inhaled medication called treprostinil using a nebulizer for patients with idiopathic pulmonary fibrosis.See study design
What are the potential side effects?
While not specified here, inhaled treprostinil may cause coughing, headaches, throat irritation, nausea, flushing or dizziness as common side effects based on its mode of administration and pharmacology.

TETON-OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Long-term safety and tolerability of inhaled treprostinil in subjects with IPF

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%
Chronic respiratory failure
1%
Sepsis
1%
Chronic obstructive pulmonary disease
1%
Pulmonary hypertension
1%
Bronchitis
1%
Pneumothorax
1%
Pain in extremity
1%
Bronchopulmonary aspergillosis
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-OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Inhaled TreprostinilExperimental Treatment2 Interventions
Treprostinil 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 to a target of 15 breaths QID or until the subject reaches their maximum clinically tolerated dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled Treprostinil
2017
Completed Phase 3
~330

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
107 Previous Clinical Trials
12,595 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
1,167 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Inhaled Treprostinil (Prostacyclin Analogue) Clinical Trial Eligibility Overview. Trial Name: NCT04905693 — Phase 3
Idiopathic Pulmonary Fibrosis Research Study Groups: Inhaled Treprostinil
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Inhaled Treprostinil Highlights & Side Effects. Trial Name: NCT04905693 — Phase 3
Inhaled Treprostinil (Prostacyclin Analogue) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905693 — 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 any other published reports on the effects of inhaled treprostinil?

"Treprostinil was first introduced in 2015 via a clinical study at Arkansas Children's Hospital. In the 5 years since, it has been trialed 46 times with 9 ongoing studies. Many of these are based in Orlando, FL."

Answered by AI

How is Inhaled Treprostinil typically employed?

"Inhaled Treprostinil is most frequently used to help patients in NYHA Functional Class III, as well as those with pulmonary arterial hypertension. It can also improve quality of life for WHO Functional Class II and III patients that suffer from PAH."

Answered by AI

Has this research been undertaken before?

"Treprostinil, when inhaled, was first studied in 2015. The original clinical trial was conducted that year and funded by United Therapeutics. This initial Phase 1 study had 70 participants. After the success of this first trial, Inhaled Treprostinil went on to receive Phase 2 drug approval in ____. Currently, there are 9 active clinical trials taking place in 101 cities across 6 countries."

Answered by AI

How many people are being signed up for this clinical trial?

"As of now, this trial is not enrolling patients. The last time the listing was edited on clinicaltrials.gov was September 21st, 2022. If you are seeking other studies, 717 trials for usual interstitial pneumonia and 9 for Inhaled Treprostinil are still recruiting participants."

Answered by AI

Has inhaled Treprostinil received approval from the FDA?

"Inhaled Treprostinil has received a score of 3 for safety. This is due to the fact that it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI

Can patients still join this research project?

"Data from clinicaltrials.gov suggests that this particular trial is not seeking participants at the moment. This information could be subject to change as the last update was on September 21st, 2022. However, there are over 700 other trials with open recruitment currently underway."

Answered by AI

Which hospitals are running this research project within our state?

"7 locations are recruiting patients for this trial, these include Central Florida Pulmonary Group, PA in Orlando, Tulane University Medical Center in New Orleans and Pulmonary Associates of Richmond, Inc. in Richmond. 4 other sites are also part of this study."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Tulane University Medical Center
Renovatio Clinical
Community Health Network
Other

Why did patients apply to this trial?

I’ve been on OFEV for about ten years and would like to see if there’s an alternative.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
2022. "Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04905693.
All > Lung Disease > Idiopathic Pulmonary Fibrosis
~40 spots leftby Jun 2024
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