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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.

Must not have

Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC <0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).

Subject is receiving >10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe lung obstruction or more damage from emphysema than scarring on a lung scan.

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I need more than 10 liters per minute of oxygen to breathe normally when resting.

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I have been diagnosed with idiopathic pulmonary fibrosis.

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I had a bad reaction or no improvement with a specific heart or lung treatment, leading to its discontinuation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Absolute FVC from Baseline to Week 52

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

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

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

0 / 8Eligibility criteria met