Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary DiseasePhase 2/3SUMMIT OLENCT07923526
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
A Phase 2/3 study testing treprostinil SMI (treprostinil inhalation spray) in people with Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 15 sites in United States.
Trial summary
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. 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?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2027to Sep 2034
- Phase
- Phase 2/3
- 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
- Voluntarily give informed consent to participate in the study
- Willing and able to comply with scheduled study visits, study treatment, laboratory tests, and all other study-related procedures
- Enrolled in a previous study evaluating treprostinil SMI for PH-COPD, remained on study drug, and completed the study OR Enrolled in a previous study evaluating treprostinil SMI for PH-COPD when the study was discontinued by the Sponsor for reasons other than safety
- Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at study entry) 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 use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Who cannot join
- Pregnant or lactating
- 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). Participation in non-interventional, observational, or registry studies is permitted.
- Developed a concurrent illness or condition when using treprostinil SMI for PH-COPD in a previous study, which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites
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: An Open-label Extension Study of Treprostinil Administered Via a Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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.
Read the detailed description
SMI-PH-202 is an open-label extension (OLE) study evaluating the long-term impact of treprostinil SMI on safety, tolerability, and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study. Eligible participants will be enrolled and initiate open-label treprostinil SMI in a single arm; there is inherently no control or comparator arm. Participants will return for in-clinic visits at Weeks 4 and 12 and every 12 weeks thereafter. Treatment with treprostinil SMI will continue until the participant either prematurely discontinues treatment, marketing approval of treprostinil SMI for PH-COPD is granted, or the study is discontinued by the Sponsor. Participants may remain in the study for up to 7.5 years.
- Being tested
- treprostinil SMI (treprostinil 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, 5.36, and 6.70 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| treprostinil SMI | Experimental | Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, 5.36 and 6.70 mg/mL Receives: Combination Product: treprostinil SMI (treprostinil inhalation spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious AEs (SAEs)
Number and type of AEs and SAEs observed in participants during and after use of treprostinil SMI.
Measured: Up to 7.5 years
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: Up to 7.5 years
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: Up to 7.5 years
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: Up to 7.5 years
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: Up to 7.5 years
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: Up to 7.5 years
Change in the saturation of peripheral capillary oxygenation (SpO2)
Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
Measured: Up to 7.5 years
Change in supplemental oxygen use
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
Measured: Up to 7.5 years
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: Up to 7.5 years
Secondary outcomes (6)
Change in peak 6-Minute Walk Distance (6MWD) over time
The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD over time 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: Up to 7.5 years
Change in N-terminal pro brain natriuretic peptide (NT-proBNP) over time
NT-proBNP is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will assess the severity of heart failure over time.
Measured: Up to 7.5 years
Change in emPHasis-10 assessment over time
The emPHasis-10 is a validated, 10-item questionnaire focused on the impact of PH on daily activity. The total score ranges from 0 to 50 with a higher score indicating worse health-related quality of life.
Measured: Up to 7.5 years
Change in COPD Assessment Test (CAT) over time
The CAT is a validated, 8-item questionnaire that measures the impact of COPD symptoms on daily life and wellbeing. The total score ranges from 0 to 40 with a higher score indicating greater symptom-related burden.
Measured: Up to 7.5 years
Change in Patient Global Impressions - Change (PGI-C) scale over time
The PGI-C scale is a single question that assesses the patient's perspective on how their symptoms have changed over time. The PGI-C provides a subjective summary index with a low score indicating improvement and a high score indicating worsening.
Measured: Up to 7.5 years
Change in modified Medical Research Council (mMRC) scale over time
The mMRC scale is a validated, single question to assess dyspnea, using a scale of 0 to 4 with a score of 4 indicating the worst level of breathlessness.
Measured: Up to 7.5 years
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 startMar 2027 (estimated)
- Primary completionSep 2034 (estimated)
- Study completionSep 2034 (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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT07923526
- Sponsor's protocol ID
- SMI-PH-202
- Acronym
- SUMMIT OLE
- 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
- An Open-label Extension Study 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
- NCT07923526
- Acronym / sponsor ID
- SUMMIT OLE / SMI-PH-202
- Keywords
- pulmonary hypertension, lung disease, respiratory tract disease, pulmonary hypertension associated with chronic obstructive pulmonary disease, chronic obstructive pulmonary disease, COPD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Sep 2034 (estimated)
- Study completion
- Sep 2034 (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 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.
Detailed description
SMI-PH-202 is an open-label extension (OLE) study evaluating the long-term impact of treprostinil SMI on safety, tolerability, and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study. Eligible participants will be enrolled and initiate open-label treprostinil SMI in a single arm; there is inherently no control or comparator arm. Participants will return for in-clinic visits at Weeks 4 and 12 and every 12 weeks thereafter. Treatment with treprostinil SMI will continue until the participant either prematurely discontinues treatment, marketing approval of treprostinil SMI for PH-COPD is granted, or the study is discontinued by the Sponsor. Participants may remain in the study for up to 7.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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, 5.36 and 6.70 mg/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily give informed consent to participate in the study
- Willing and able to comply with scheduled study visits, study treatment, laboratory tests, and all other study-related procedures
- Enrolled in a previous study evaluating treprostinil SMI for PH-COPD, remained on study drug, and completed the study OR Enrolled in a previous study evaluating treprostinil SMI for PH-COPD when the study was discontinued by the Sponsor for reasons other than safety
- Women of childbearing potential (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at study entry) and nonlactating and agree to use 1 of the following:
- 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.
Key exclusion criteria (3 listed)
- Pregnant or lactating
- 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). Participation in non-interventional, observational, or registry studies is permitted.
- Developed a concurrent illness or condition when using treprostinil SMI for PH-COPD in a previous study, which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
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, 5.36, and 6.70 mg/mL | Combination product | treprostinil SMI |
Primary outcome
Incidence of adverse events (AEs) and serious AEs (SAEs)
Time frame: Up to 7.5 years
Number and type of AEs and SAEs observed in participants during and after use of treprostinil SMI.
Change in Forced Expiratory Volume in One Second (FEV1) as % predicted
Time frame: Up to 7.5 years
FEV1 is a standard indicator of lung function and measures the maximal amount of air forcefully exhaled in 1 second.
Change in Forced Vital Capacity (FVC) in mL
Time frame: Up to 7.5 years
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.
Change in FEV1/FVC ratio
Time frame: Up to 7.5 years
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.
Change in Total Lung Capacity (TLC) in mL
Time frame: Up to 7.5 years
TLC is a standard indicator of lung function and measures the maximum volume of lung capacity after very deep inhalation.
Change in Lung Diffusion Capacity (DLCO) as % predicted
Time frame: Up to 7.5 years
DLCO is a standard indicator of lung function and measures how well oxygen moves from the lungs to the blood.
Change in the saturation of peripheral capillary oxygenation (SpO2)
Time frame: Up to 7.5 years
Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
Change in supplemental oxygen use
Time frame: Up to 7.5 years
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
Change in 12-lead electrocardiogram (ECG)
Time frame: Up to 7.5 years
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).
6 secondary outcomes
Change in peak 6-Minute Walk Distance (6MWD) over time
Time frame: Up to 7.5 years
Change in N-terminal pro brain natriuretic peptide (NT-proBNP) over time
Time frame: Up to 7.5 years
Change in emPHasis-10 assessment over time
Time frame: Up to 7.5 years
Change in COPD Assessment Test (CAT) over time
Time frame: Up to 7.5 years
Change in Patient Global Impressions - Change (PGI-C) scale over time
Time frame: Up to 7.5 years
Change in modified Medical Research Council (mMRC) scale over time
Time frame: Up to 7.5 years
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
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing treprostinil SMI (treprostinil inhalation spray) in people with Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 15 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 8 inclusion and 3 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 15 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 adverse events (AEs) and serious AEs (SAEs) (time frame: Up to 7.5 years). The study lists 9 primary outcomes in all. 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.