A Phase 2/3 interventional study of treprostinil SMI (treprostinil inhalation spray) in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, sponsored by United Therapeutics. Not yet recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by United Therapeutics · Phase 2/3, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 400 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →United Therapeutics is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women of (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 (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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhaled treprostinil administered via a SMI at concentrations of 1.34, 2.68, 4.02, 5.36 and 6.70 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, 5.36, and 6.70 mg/mL
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7.5 years
Change in supplemental oxygen use
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
Time frame: 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).
Time frame: Up to 7.5 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7.5 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Sep 2034, 90 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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