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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%
Bronchopulmonary aspergillosis
1%
Sepsis
1%
Pulmonary hypertension
1%
Pain in extremity
1%
Bronchitis
1%
Chronic obstructive pulmonary disease
1%
Chronic respiratory failure
1%
Pneumothorax
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
108 Previous Clinical Trials
13,601 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
~297 spots leftby Jun 2025
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