Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
NCT07923591, Phase 2, Not yet recruiting, United Therapeutics
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) | ClinicalTrials.gov |
| NCT number | NCT07923591 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | United Therapeutics | ClinicalTrials.gov |
| Conditions | Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease | ClinicalTrials.gov |
| Interventions | treprostinil SMI (treprostinil inhalation spray), Placebo (placebo inhalation spray) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of serious adverse events, severe adverse events, cardiopulmonary hospitalizations, and deaths | 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. | ClinicalTrials.gov |
| Secondary | Change in peak 6-Minute Walk Distance (6MWD) from baseline to Week 16 | 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. | ClinicalTrials.gov |
| Secondary | Change in trough 6MWD from baseline to Week 15 | 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. | ClinicalTrials.gov |
| Secondary | Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to Week 16 | 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. | ClinicalTrials.gov |
| Secondary | Change in overall adverse events | 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. | ClinicalTrials.gov |
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1) as % predicted | 16 weeks | FEV1 is a standard indicator of lung function and measures the maximal amount of air forcefully exhaled in 1 second. | ClinicalTrials.gov |
| Secondary | Change in Forced Vital Capacity (FVC) in mL | 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. | ClinicalTrials.gov |
| Secondary | Change in FEV1/FVC ratio | 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. | ClinicalTrials.gov |
| Secondary | Change in Total Lung Capacity (TLC) in mL | 16 weeks | TLC is a standard indicator of lung function and measures the maximum volume of lung capacity after very deep inhalation. | ClinicalTrials.gov |
| Secondary | Change in Lung Diffusion Capacity (DLCO) as % predicted | 16 weeks | DLCO is a standard indicator of lung function and measures how well oxygen moves from the lungs to the blood. | ClinicalTrials.gov |
| Secondary | Change in the saturation of peripheral capillary oxygenation (SpO2) | 16 weeks | Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress. | ClinicalTrials.gov |
| Secondary | Change in supplemental oxygen use | 16 weeks | Supplemental oxygen use, as measured in L, indicates chronic hypoxemia. | ClinicalTrials.gov |
| Secondary | Change in 12-lead electrocardiogram (ECG) | 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). | ClinicalTrials.gov |
| Secondary | Incidence of acute exacerbations of COPD | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)