Trial · NCT03496623
A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)
NCT03496623, Phase 3, Terminated, United Therapeutics; results first posted 2023-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT03496623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496623
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT03496623
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 188 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
- Interventions
- Inhaled treprostinil solution, Placebo solution
- First posted
- 2018-04-12
- Last updated
- 2023-11-24
- Results first posted
- 2023-11-24
- Limitations and caveats
- Per sponsor decision, the study was terminated early. Data were not collected for the secondary outcome measures due to study termination and lack of appropriate sample size.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Baseline, Week 12 | 6 MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6MWT was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded. Statistical analyses were not performed due to lack of appropriate sample size. |
| Secondary | Change From Baseline to Week 12 in Moderate to Vigorous Physical Activity (MVPA) | Baseline, Week 12 | MVPA was defined as the number of minutes spent in moderate to vigorous physical activity as measured via a wrist-worn medical grade physical activity monitor. The screening data were used to establish a baseline level of physical activity. |
| Secondary | Change From Baseline to Week 12 in Overall Activity | Baseline, Week 12 | Overall activity was defined as the number of minutes spent in overall activity (non-sedentary activity) as measured via a wrist-worn medical grade physical activity monitor. The screening data will be used to establish a baseline level of physical activity. |
| Secondary | Change From Baseline to Week 12 in Borg Dyspnea Score | Baseline, Week 12 | The Borg Dyspnea Score was a 11-point scale rating the maximum level of dyspnea experienced during the 6-minute walking test (6MWT). Scores range from 0 (no dyspnea at all) to 10 (very, very severe dyspnea), with lower scores indicating a less exertion (a better outcome). The Borg Dyspnea Score was to be evaluated immediately after the 6MWT. |
| Secondary | Change From Baseline to Week 12 in 6MWD/Borg Dyspnea Composite Score | Baseline, Week 12 | 6MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6MWT was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded. The Borg Dyspnea Score was an 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (no dyspnea at all) to 10 (very, very severe dyspnea), with lower scores indicating less exertion (a better outcome). The Borg Dyspnea Score was to be evaluated immediately after the 6MWT. The average 6WMWD data and the average Borg Dyspnea Composite Score data were summed and reported as the composite score. |
| Secondary | Change From Baseline to Week 12 in Quality of Life (QOL) Measured by St. George's Respiratory Questionnaire (SGRQ) | Baseline, Week 12 | The SGRQ is a designed to measure how breathing impacts overall health, daily life, and perceived well-being in participants with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating a better QoL. |
| Secondary | Change From Baseline to Week 12 in QOL Measured by the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) | Baseline, Week 12 | The UCSD SOBQ is a self-administered rating of dyspnea associated with activities of daily living. The questionnaire uses a 6-point scale where 0 = "not at all" and 5 = "maximal or unable to do because of breathlessness". Lower scores indicate a better QoL. |
| Secondary | Change From Baseline to Week 12 in Plasma Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Levels | Baseline, Week 12 | The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function. Improvement is defined as a decrease in the NT-proBNP plasma concentration. |
| Secondary | Change From Baseline to Week 12 in Patient Global Assessment (PGA) | Baseline, Week 12 | The PGA is used to rate participant fatigue and shortness of breath. Participants will use the Sponsor-provided smart device for at-home capture of PGA data. The PGA used a 5-point response scale of: "never," "rarely," "sometimes," "often," or "always" with higher scores indicating a worse symptom rating. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants evaluable at the specified timeframe. | meters | MEAN |
| SECONDARY | Change From Baseline to Week 12 in Moderate to Vigorous Physical Activity (MVPA) | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in Overall Activity | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in Borg Dyspnea Score | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in 6MWD/Borg Dyspnea Composite Score | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in Quality of Life (QOL) Measured by St. George's Respiratory Questionnaire (SGRQ) | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in QOL Measured by the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in Plasma Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Levels | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. | ||
| SECONDARY | Change From Baseline to Week 12 in Patient Global Assessment (PGA) | Baseline, Week 12 | Full Analysis Set included all participants who were randomized and received at least one dose of study drug. Data were not collected for this outcome measure due to study termination and lack of appropriate sample size. |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Original Crossover Design - Treprostinil | Baseline | 225.07 | Standard Deviation 77.41 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Original Crossover Design - Placebo | Baseline | 220.47 | Standard Deviation 77.64 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Contingent Parallel Design - Treprostinil | Baseline | 231.50 | Standard Deviation 60.77 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Contingent Parallel Design - Placebo | Baseline | 283.00 | Standard Deviation 67.78 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Original Crossover Design - Treprostinil | Change at Week 12 | -4.47 | Standard Deviation 39.01 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Original Crossover Design - Placebo | Change at Week 12 | -5.14 | Standard Deviation 50.71 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Contingent Parallel Design - Treprostinil | Change at Week 12 | 20.33 | Standard Deviation 116.99 | meters |
| Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD) | Contingent Parallel Design - Placebo | Change at Week 12 | 18.5 | Standard Deviation 42.49 | meters |
Source ClinicalTrials.gov
Participant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Period (2 Weeks) | STARTED | Run-In | 108 | |
| Run-In Period (2 Weeks) | STARTED | Original Crossover Design - Treprostinil, Then Placebo | 0 | |
| Run-In Period (2 Weeks) | STARTED | Original Crossover Design - Placebo, Then Treprostinil | 0 | |
| Run-In Period (2 Weeks) | STARTED | Contingent Parallel Design - Treprostinil | 0 | |
| Run-In Period (2 Weeks) | STARTED | Contingent Parallel Design - Placebo | 0 | |
| Run-In Period (2 Weeks) | Received At Least 1 Dose of Study Drug | Run-In | 108 | |
| Run-In Period (2 Weeks) | Received At Least 1 Dose of Study Drug | Original Crossover Design - Treprostinil, Then Placebo | 0 | |
| Run-In Period (2 Weeks) | Received At Least 1 Dose of Study Drug | Original Crossover Design - Placebo, Then Treprostinil | 0 | |
| Run-In Period (2 Weeks) | Received At Least 1 Dose of Study Drug | Contingent Parallel Design - Treprostinil | 0 | |
| Run-In Period (2 Weeks) | Received At Least 1 Dose of Study Drug | Contingent Parallel Design - Placebo | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events162
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 |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Run-In | 2 | 108 | |
| other | Fatigue | General disorders | Treprostinil | 7 | 66 | |
| other | Fatigue | General disorders | Placebo | 2 | 58 | |
| other | Chest discomfort | General disorders | Run-In | 3 | 108 | |
| other | Chest discomfort | General disorders | Treprostinil | 5 | 66 | |
| other | Chest discomfort | General disorders | Placebo | 0 | 58 | |
| other | Upper respiratory tract infection | Infections and infestations | Run-In | 1 | 108 | |
| other | Upper respiratory tract infection | Infections and infestations | Treprostinil | 2 | 66 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 4 | 58 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Run-In | 0 | 108 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Run-In | 1 | 108 |
| Total, all-cause mortality | Treprostinil | 5 | 66 |
| Total, all-cause mortality | Placebo | 0 | 58 |
| Total, other adverse events | Run-In | 50 | 108 |
| Total, other adverse events | Treprostinil | 36 | 66 |
| Total, other adverse events | Placebo | 25 | 58 |
| Total, serious adverse events | Run-In | 9 | 108 |
| Total, serious adverse events | Treprostinil | 17 | 66 |
| Total, serious adverse events | Placebo | 6 | 58 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38811045 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03496623
GET https://conductscience.org/api/trials/v1/NCT03496623/flow?page=2