Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (SUMMIT 201)

November 2, 2026 updated by: United Therapeutics

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety and Tolerability of Treprostinil Administered Via a Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SMI-PH-201 is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, safety and tolerability study with secondary endpoints evaluating the efficacy of the study drug on exercise capacity and NT-proBNP.

Eligible participants will be randomly assigned 1:1 to treprostinil SMI or placebo at the Baseline Visit and receive study drug over a 16-week period. Participants will return to the clinic for follow-up visits at Weeks 4, 8, 12, 15, and 16.

Study drug will be administered via a combination drug-device product that consists of the SMI with an associated cartridge containing a propellant-free, liquid-based formulation of treprostinil inhalation spray. Participants will receive study drug in multi-use cartridges containing either treprostinil (in concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL) or placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham, Lung Health Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenix
      • Tucson, Arizona, United States, 85719
        • University of Arizona/Banner Health
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Health Care
      • San Francisco, California, United States, 94143
        • University of California San Francisco Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina at Chapel HIll
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Give voluntary informed consent to participate in the study

  2. Are ≥18 years of age, inclusive, at the time of signing informed consent

  3. Willing to undergo right heart catheterization (RHC) during Screening. A RHC performed within 12 months prior to the Baseline Visit is acceptable for determining eligibility, even if done without oxygen or vasodilator challenge, and repeat RHC is not required. The following parameters must be documented for eligibility:

    1. Pulmonary vascular resistance ≥4 Wood units
    2. Pulmonary capillary wedge pressure or left ventricular end diastolic pressure ≤15 mmHg

  4. Diagnosis of PH-COPD (WHO Group 3) with the following documented parameters at Screening:

    1. FEV1 ≥35%
    2. FEV1/FVC <70%

  5. Resting SpO2 ≥90%, with or without supplemental oxygen by any mode of delivery and supplemental O2 ≤8 L/min at rest at Screening

  6. If on chronic COPD medication, must be on a stable and optimized dose for ≥45 days prior to the Baseline Visit

  7. Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at Screening and Baseline) and nonlactating and agree to use 1 of the following:

    1. Abstain from penile-vaginal intercourse (when it is in line with their preferred and usual lifestyle) OR
    2. Use medically acceptable, highly effective contraception for the duration of the study and at least 30 days after discontinuing study drug. Medically acceptable, highly effective forms of contraception include approved hormonal contraceptives (oral, injectable, transdermal, intravaginal, and implantable), hormonal or non-hormonal intrauterine devices or systems, or monogamous intercourse with a partner who has undergone vasectomy. Barrier methods alone or with spermicide may be considered with Sponsor approval if they have a proven track record of excellent compliance. Note: Women who are successfully sterilized (including hysterectomy, bilateral salpingectomy, bilateral tubal occlusion, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea for at least 12 consecutive months and >50 years of age or in the documented clinical opinion of a Women's Health Specialist) are not considered to be WOCBP for study purposes.

  8. Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug

  9. In the opinion of the Investigator, able to communicate effectively with study site staff, and considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits

Exclusion Criteria:

  1. 6MWD <150 meters during Screening

  2. DLCO ≤25% during Screening

  3. Pregnant or lactating

  4. Known intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy

  5. Confirmed diagnosis of PAH or PH for any reason other than associated with COPD

  6. Received any PAH-approved therapy within 60 days prior to Baseline. As needed (PRN) use of a PDE5-I (eg, sildenafil, tadalafil, vardenafil) for erectile dysfunction is permitted. Daily use of a PDE5-I, even if for an indication other than PH, is not allowed.

  7. Unable or unwilling to use Sponsor-provided devices (eg, SMI)

  8. Confirmed diagnosis of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease, or interstitial lung disease. Redacted computed tomography scan results conducted within 6 months prior to Baseline must be provided to the Sponsor's Medical Monitor with the Pre Baseline Form to confirm eligibility.

  9. Previous diagnosis of homozygous alpha-1 antitrypsin deficiency

  10. Myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline

  11. Evidence of clinically significant left-sided heart disease (including, but not limited to, left ventricular ejection fraction <40% and/or left ventricular hypertrophy) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor's Medical Monitor is required.

  12. Any form of congenital heart disease (repaired or unrepaired) other than a patent foramen ovale

  13. Recent exacerbation of COPD and/or active pulmonary or upper respiratory infection that required hospitalization, symptomatic treatment, or treatment with antibiotics and/or corticosteroids:

    1. If hospitalized, within 180 days prior to Baseline
    2. If not hospitalized, within 90 days prior to Baseline

  14. Initiation of pulmonary rehabilitation within 12 weeks prior to Baseline or, in the opinion of the Investigator, pulmonary rehabilitation is likely to be needed during the Treatment Period

  15. Use of any other investigational drug/device or participation in any investigational study in which the participant received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Baseline. Participation in non-interventional, observational, or registry studies is permitted.

  16. In the opinion of the Investigator, the participant has any condition that would interfere with the interpretation of study assessments, study participation or cooperation, or has any disease or condition (ie, peripheral vascular disease, musculoskeletal disorder, morbid obesity) that would likely be the primary limit to ambulation (as opposed to PH)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: treprostinil SMI

Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL
Combination product: treprostinil SMI (treprostinil inhalation spray)

Inhaled treprostinil administered via a SMI four times daily in concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL
Placebo Comparator: placebo

Inhaled placebo administered via a SMI
Combination product: Placebo (placebo inhalation spray)

Placebo administered via a SMI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths
Time Frame: 16 weeks

Number and type of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths observed in participants during and after use of inhaled treprostinil and placebo.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in peak 6-Minute Walk Distance (6MWD) from baseline to Week 16
Time Frame: 16 weeks

The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from baseline to Week 16 correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Participants will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Peak exposure 6MWD will occur by conducting the 6-minute walk test within 10 to 60 minutes after the most recent dose of study drug.
16 weeks
Change in trough 6MWD from baseline to Week 15
Time Frame: 15 weeks

The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from baseline to Week 15 correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Participants will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Trough exposure 6MWD will occur by conducting 6-minute walk test at least four hours after the most recent study drug dose.
15 weeks
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 16
Time Frame: 16 weeks

The NT-proBNP serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at baseline and Week 16.
16 weeks
Change in overall adverse events
Time Frame: 16 weeks

The incidence of adverse events among participants throughout the 16-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.
16 weeks
Change in Forced Expiratory Volume in One Second (FEV1) as % predicted
Time Frame: 16 weeks

FEV1 is a standard indicator of lung function and measures the maximal amount of air forcefully exhaled in 1 second.
16 weeks
Change in Forced Vital Capacity (FVC) in mL
Time Frame: 16 weeks

FVC is a standard indicator of lung function and measures the amount of air a person can forcefully and quickly exhale after taking a deep breath.
16 weeks
Change in FEV1/FVC ratio
Time Frame: 16 weeks

The FEV1/FVC ratio measures how much air is exhaled in one second compared to a full breath. This helps determine if the lung condition is restrictive or obstructive and its severity.
16 weeks
Change in Total Lung Capacity (TLC) in mL
Time Frame: 16 weeks

TLC is a standard indicator of lung function and measures the maximum volume of lung capacity after very deep inhalation.
16 weeks
Change in Lung Diffusion Capacity (DLCO) as % predicted
Time Frame: 16 weeks

DLCO is a standard indicator of lung function and measures how well oxygen moves from the lungs to the blood.
16 weeks
Change in the saturation of peripheral capillary oxygenation (SpO2)
Time Frame: 16 weeks

Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
16 weeks
Change in supplemental oxygen use
Time Frame: 16 weeks

Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
16 weeks
Change in 12-lead electrocardiogram (ECG)
Time Frame: 16 weeks

The 12-lead ECG measures electrical cardiac activity, including heart rate and rhythm (PR interval, QT interval, QT interval corrected for heart rate by Fridericia's formula, and QRS duration).
16 weeks
Incidence of acute exacerbations of COPD
Time Frame: 16 weeks

An acute exacerbation of COPD is defined as an event characterized by increased dyspnea and/or cough and sputum that worsens in <14 days, which may be accompanied by tachypnea and/or tachycardia, and is often associated with increased local and systemic inflammation caused by infection, pollution, or other insult to the airways. For this study, the following diagnostic criteria will be used to support a diagnosis of acute COPD exacerbation:

  • Previous or concurrent diagnosis of COPD
  • Acute worsening or development of dyspnea typically of less than 14-day duration
  • Deterioration not fully explained by heart failure, pneumonia, or pulmonary embolism
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMI-PH-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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