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Treprostinil Inhalation for Pulmonary Hypertension in COPD

(SUMMIT OLE Trial)

Not yet recruiting at 14 trial locations
UT
Overseen ByUnited Therapeutics Global Medical Information
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: United Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term impact of treprostinil SMI on safety and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study.

Are You a Good Fit for This Trial?

This trial is for people with pulmonary hypertension linked to COPD who have already taken part in a previous Phase 2 or 3 study of inhaled treprostinil. Participants must meet the requirements from their earlier study and not have new health issues that would prevent safe participation.

Inclusion Criteria

I am a woman who is either sterilized or postmenopausal.
I will use a condom during treatment and for 48 hours after stopping the study drug.
I am not pregnant or breastfeeding and will use effective birth control during the study.
See 4 more

Exclusion Criteria

Pregnant or lactating
Developed a concurrent illness or condition during previous use of treprostinil SMI for PH-COPD that would pose a health risk if enrolled in this study, as judged by the Investigator
I am not using any other experimental drugs or devices.

What Are the Treatments Tested in This Trial?

Interventions

  • treprostinil SMI

Trial Overview

The study is testing long-term use of treprostinil as an inhaled spray (SMI) in people with PH-COPD. All participants receive the medication, and researchers will monitor its safety and effectiveness over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: treprostinil SMIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

United Therapeutics

Lead Sponsor

Trials
112
Recruited
14,500+

Dr. Martine Rothblatt

United Therapeutics

Chief Executive Officer since 1996

PhD in Medical Ethics from the Royal London College of Medicine and Dentistry, JD and MBA from UCLA

Dr. Michael Benkowitz

United Therapeutics

Chief Medical Officer since 2023

MD from Harvard Medical School

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