Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary DiseasePhase 2SUMMIT 201NCT07923591
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
A Phase 2 study testing treprostinil SMI (treprostinil inhalation spray) in people with Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 16 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
- What is being tested?
- treprostinil SMI (treprostinil inhalation spray)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 16 sitesUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give voluntary informed consent to participate in the study
- Are ≥18 years of age, inclusive, at the time of signing informed consent
- 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:
- Pulmonary vascular resistance ≥4 Wood units
- Pulmonary capillary wedge pressure or left ventricular end diastolic pressure ≤15 mmHg
- Diagnosis of PH-COPD (WHO Group 3) with the following documented parameters at Screening:
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- FEV1 ≥35%
- FEV1/FVC <70%
- Resting SpO2 ≥90%, with or without supplemental oxygen by any mode of delivery and supplemental O2 ≤8 L/min at rest at Screening
- If on chronic COPD medication, must be on a stable and optimized dose for ≥45 days prior to the Baseline Visit
- 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:
- Abstain from penile-vaginal intercourse (when it is in line with their preferred and usual lifestyle) OR
- 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.
- 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
- 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
Who cannot join
- 6MWD <150 meters during Screening
- DLCO ≤25% during Screening
- Pregnant or lactating
- Known intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy
- Confirmed diagnosis of PAH or PH for any reason other than associated with COPD
- 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.
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- Unable or unwilling to use Sponsor-provided devices (eg, SMI)
- 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.
- Previous diagnosis of homozygous alpha-1 antitrypsin deficiency
- Myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline
- 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.
- Any form of congenital heart disease (repaired or unrepaired) other than a patent foramen ovale
- Recent exacerbation of COPD and/or active pulmonary or upper respiratory infection that required hospitalization, symptomatic treatment, or treatment with antibiotics and/or corticosteroids:
- If hospitalized, within 180 days prior to Baseline
- If not hospitalized, within 90 days prior to Baseline
- 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
- 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.
- 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)
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites
University of Alabama at Birmingham, Lung Health Center
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel HIll
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medical Center
Chicago, Illinois, 60637
Baylor University Medical Center
Dallas, Texas, 75246
Henry Ford Health System
Detroit, Michigan, 48202
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Kentucky
Lexington, Kentucky, 40536
Stanford Health Care
Palo Alto, California, 94305
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Arizona/Banner Health
Tucson, Arizona, 85719
About this study
Official title: 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.
Read the 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.
- Being tested
- treprostinil SMI (treprostinil inhalation spray), Placebo (placebo inhalation spray)
- Keywords
- pulmonary hypertension, lung disease, respiratory tract disease, pulmonary hypertension associated with chronic obstructive pulmonary disease, chronic obstructive pulmonary disease, COPD
- Medical subject headings
- Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treprostinil SMI (treprostinil inhalation spray)Combination product
Inhaled treprostinil administered via a SMI four times daily in concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL
Placebo (placebo inhalation spray)Combination product
Placebo administered via a SMI
| Study group | Role | What they receive |
|---|---|---|
| treprostinil SMI | Experimental | Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL Receives: Combination Product: treprostinil SMI (treprostinil inhalation spray) |
| placebo | Placebo comparator | Inhaled placebo administered via a SMI Receives: Combination Product: Placebo (placebo inhalation spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths
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.
Measured: 16 weeks
Secondary outcomes (13)
Change in peak 6-Minute Walk Distance (6MWD) from baseline to Week 16
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.
Measured: 16 weeks
Change in trough 6MWD from baseline to Week 15
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.
Measured: 15 weeks
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 16
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.
Measured: 16 weeks
Change in overall adverse events
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.
Measured: 16 weeks
Change in Forced Expiratory Volume in One Second (FEV1) as % predicted
FEV1 is a standard indicator of lung function and measures the maximal amount of air forcefully exhaled in 1 second.
Measured: 16 weeks
Change in Forced Vital Capacity (FVC) in mL
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.
Measured: 16 weeks
Change in FEV1/FVC ratio
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.
Measured: 16 weeks
Change in Total Lung Capacity (TLC) in mL
TLC is a standard indicator of lung function and measures the maximum volume of lung capacity after very deep inhalation.
Measured: 16 weeks
Change in Lung Diffusion Capacity (DLCO) as % predicted
DLCO is a standard indicator of lung function and measures how well oxygen moves from the lungs to the blood.
Measured: 16 weeks
Change in the saturation of peripheral capillary oxygenation (SpO2)
Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
Measured: 16 weeks
Change in supplemental oxygen use
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
Measured: 16 weeks
Change in 12-lead electrocardiogram (ECG)
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).
Measured: 16 weeks
Incidence of acute exacerbations of COPD
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923591
- Sponsor's protocol ID
- SMI-PH-201
- Acronym
- SUMMIT 201
- Status last verified
- Nov 2026
- First submitted
- 19 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07923591
- Acronym / sponsor ID
- SUMMIT 201 / SMI-PH-201
- Keywords
- pulmonary hypertension, lung disease, respiratory tract disease, pulmonary hypertension associated with chronic obstructive pulmonary disease, chronic obstructive pulmonary disease, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treprostinil SMI | Experimental | Combination Product: treprostinil SMI (treprostinil inhalation spray)Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, and 5.36 mg/mL |
| placebo | Placebo comparator | Combination Product: Placebo (placebo inhalation spray)Inhaled placebo administered via a SMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Give voluntary informed consent to participate in the study
- Are ≥18 years of age, inclusive, at the time of signing informed consent
- 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:
- Diagnosis of PH-COPD (WHO Group 3) with the following documented parameters at Screening:
- Resting SpO2 ≥90%, with or without supplemental oxygen by any mode of delivery and supplemental O2 ≤8 L/min at rest at Screening
Key exclusion criteria (18 listed)
- 6MWD <150 meters during Screening
- DLCO ≤25% during Screening
- Pregnant or lactating
- Known intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy
- Confirmed diagnosis of PAH or PH for any reason other than associated with COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination product | treprostinil SMI |
| Placebo (placebo inhalation spray)Placebo administered via a SMI | Combination product | placebo |
Primary outcome
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.
13 secondary outcomes
Change in peak 6-Minute Walk Distance (6MWD) from baseline to Week 16
Time frame: 16 weeks
Change in trough 6MWD from baseline to Week 15
Time frame: 15 weeks
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 16
Time frame: 16 weeks
Change in overall adverse events
Time frame: 16 weeks
Change in Forced Expiratory Volume in One Second (FEV1) as % predicted
Time frame: 16 weeks
Change in Forced Vital Capacity (FVC) in mL
Time frame: 16 weeks
Change in FEV1/FVC ratio
Time frame: 16 weeks
Change in Total Lung Capacity (TLC) in mL
Time frame: 16 weeks
Change in Lung Diffusion Capacity (DLCO) as % predicted
Time frame: 16 weeks
Change in the saturation of peripheral capillary oxygenation (SpO2)
Time frame: 16 weeks
Change in supplemental oxygen use
Time frame: 16 weeks
Change in 12-lead electrocardiogram (ECG)
Time frame: 16 weeks
Incidence of acute exacerbations of COPD
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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Active, not recruitingPhase 2
Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing treprostinil SMI (treprostinil inhalation spray) in people with Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact United Therapeutics Global Medical Information (919-485-8350, clinicaltrials@unither.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.