An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
NCT07923526, Phase 2, Phase 3, Not yet recruiting, United Therapeutics
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) | ClinicalTrials.gov |
| NCT number | NCT07923526 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 400 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) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) and serious AEs (SAEs) | Up to 7.5 years | Number and type of AEs and SAEs observed in participants during and after use of treprostinil SMI. | ClinicalTrials.gov |
| Primary | Change in Forced Expiratory Volume in One Second (FEV1) as % predicted | 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. | ClinicalTrials.gov |
| Primary | Change in Forced Vital Capacity (FVC) in mL | 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. | ClinicalTrials.gov |
| Primary | Change in FEV1/FVC ratio | 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. | ClinicalTrials.gov |
| Primary | Change in Total Lung Capacity (TLC) in mL | 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. | ClinicalTrials.gov |
| Primary | Change in Lung Diffusion Capacity (DLCO) as % predicted | 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. | ClinicalTrials.gov |
| Primary | Change in the saturation of peripheral capillary oxygenation (SpO2) | Up to 7.5 years | Pulse oximetry will measure SpO2 as a percentage, indicating hypoxemia and respiratory distress. | ClinicalTrials.gov |
| Primary | Change in supplemental oxygen use | Up to 7.5 years | Supplemental oxygen use, as measured in L, indicates chronic hypoxemia. | ClinicalTrials.gov |
| Primary | Change in 12-lead electrocardiogram (ECG) | 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). | ClinicalTrials.gov |
| Secondary | Change in peak 6-Minute Walk Distance (6MWD) over time | Up to 7.5 years | 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. | ClinicalTrials.gov |
| Secondary | Change in N-terminal pro brain natriuretic peptide (NT-proBNP) over time | Up to 7.5 years | 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. | ClinicalTrials.gov |
| Secondary | Change in emPHasis-10 assessment over time | Up to 7.5 years | 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. | ClinicalTrials.gov |
| Secondary | Change in COPD Assessment Test (CAT) over time | Up to 7.5 years | 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. | ClinicalTrials.gov |
| Secondary | Change in Patient Global Impressions - Change (PGI-C) scale over time | Up to 7.5 years | 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. | ClinicalTrials.gov |
| Secondary | Change in modified Medical Research Council (mMRC) scale over time | Up to 7.5 years | 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. | 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)