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Prostaglandin Analog

Inhaled Treprostinil for Pulmonary Fibrosis

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
Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
Concomitant use of both nintedanib and pirfenidone is not permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Study Summary

This trial will study the effects of inhaled treprostinil on people with progressive pulmonary fibrosis over a year. #medical

Who is the study for?
Adults diagnosed with progressive pulmonary fibrosis, who are not pregnant or breastfeeding, can join this trial. They must use contraception if applicable and have been on certain treatments for at least 120 days. People with recent lung infections, high oxygen needs, a specific type of lung scarring called IPF, or those using certain PAH therapies recently cannot participate.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of inhaled treprostinil delivered via an ultrasonic nebulizer compared to a placebo over one year. It aims to see if this treatment can help people with worsening lung scarring despite standard care.See study design
What are the potential side effects?
Inhaled treprostinil may cause coughing, headaches, throat irritation, nausea, flushing or jaw pain. Side effects vary from person to person and some may experience more serious issues affecting their blood pressure or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung scans show more than 10% fibrosis.
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I am not taking nintedanib and pirfenidone at the same time.
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I have a progressive lung disease other than IPF, worsening despite treatment.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies 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

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

Who is running the clinical trial?

United TherapeuticsLead Sponsor
107 Previous Clinical Trials
12,689 Total Patients Enrolled
7 Trials studying Pulmonary Fibrosis
2,528 Patients Enrolled for Pulmonary Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for prospective participants in this experiment?

"As per the information made available on clinicaltrials.gov, this trial was posted on November 1st 2023 and last updated on September 19th 2023, indicating that it is not presently seeking participants. However, 692 other studies are actively recruiting patients right now."

Answered by AI

What safety considerations should be taken into account when administering Inhaled Treprostinil?

"There is ample evidence indicating the safety of Treprostinil, so it has been assigned a rating of 3. This drug has already gone through multiple Phase 3 trials and demonstrated both its efficacy and security."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Montefiore Medical Center

Why did patients apply to this trial?

I'VE TRIED 2 OTHER DRUGS COULDN'T TOLERATE.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
2023. "Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05943535.
All > Interstitial Lung Disease > Knoxville
~465 spots leftby Nov 2027
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