Treprostinil Inhaler for PH-COPD
(SUMMIT 201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of this study is to evaluate the safety and tolerability of treprostinil administered with a soft mist inhaler (SMI) over 16 weeks in approximately 40 participants with PH-COPD.
Are You a Good Fit for This Trial?
This trial is for adults who have both chronic obstructive pulmonary disease (COPD) and high blood pressure in the lungs (pulmonary hypertension). Participants should not have other serious lung diseases or conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- treprostinil
Trial Overview
The study is testing an inhaled medication called treprostinil, delivered by a soft mist inhaler, compared to a placebo spray. The main goal is to see if treprostinil is safe and well-tolerated over 16 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL
Inhaled placebo administered via a SMI
Find a Clinic Near You
Who Is Running the Clinical Trial?
United Therapeutics
Lead Sponsor
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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