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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
Pivotal Trial
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Long-term safety and tolerability of inhaled treprostinil in subjects with IPF
Side 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%
Pulmonary hypertension
1%
Sepsis
1%
Pain in extremity
1%
Chronic obstructive pulmonary disease
1%
Chronic respiratory failure
1%
Pneumothorax
1%
Bronchitis
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
110 Previous Clinical Trials
13,734 Total Patients Enrolled
3 Trials studying Idiopathic Pulmonary Fibrosis
1,188 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use a condom during treatment and for 48 hours after stopping the study drug.You were in a previous study and completed all the visits or were still in the study when it was stopped by the company.I am not pregnant or breastfeeding and will use two forms of birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Inhaled Treprostinil
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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