A Phase 2 interventional study of treprostinil SMI (treprostinil inhalation spray) and Placebo (placebo inhalation spray) in Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease, sponsored by United Therapeutics. Not yet recruiting at 16 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, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 40 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.
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- (WHO Group 3) with the following documented parameters at Screening:
Women of (WOCBP) must be nonpregnant (as confirmed by a pregnancy test at Screening and Baseline) and nonlactating and agree to use 1 of the following:
Exclusion Criteria:
Recent exacerbation of COPD and/or active pulmonary or upper respiratory infection that required hospitalization, symptomatic treatment, or treatment with antibiotics and/or :
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.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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, and 5.36 mg/mL
Combination Product: treprostinil SMI (treprostinil inhalation spray)
Inhaled placebo administered via a SMI
Combination Product: Placebo (placebo 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 administered via a SMI
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.
Time frame: 16 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 16 weeks
Change in the saturation of peripheral capillary oxygenation (SpO2)
Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress.
Time frame: 16 weeks
Change in supplemental oxygen use
Supplemental oxygen use, as measured in L, indicates chronic hypoxemia.
Time frame: 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).
Time frame: 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
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 50 phase 2 interventional studies under Hypertension, Pulmonary, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 71. This study's planned 18 months is below that.
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.