Trial · NCT03888365
Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH
NCT03888365, Completed, United Therapeutics; results first posted 2021-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH. Trials, record NCT03888365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03888365
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH
- NCT number
- NCT03888365
- Status
- Completed
- Enrollment
- 43 participants, actual
- Lead sponsor
- United Therapeutics
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Treprostinil, Non-Treprostinil PAH Medications
- First posted
- 2019-03-25
- Last updated
- 2021-03-16
- Results first posted
- 2021-03-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Baseline, Approximately 30 m of previous dose of inhaled treprostinil (the expected peak level) on Day 1 | A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) shortness of breath (SOB), and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Peak levels are the highest concentrations of a drug in plasma. |
| Primary | Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Baseline, Approximately 3-4 h of previous dose of inhaled treprostinil (the expected trough level) on Day 1 | A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. Trough levels are the lowest concentrations of a drug in plasma. |
| Primary | Change From Baseline in PGI-S Score in Cohort B Participants at Approximately 4 Hours After Morning Dose of Non-Treprostinil PAH Medication (Period 1) on Day 1 | Baseline, Approximately 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. |
| Primary | Change From Baseline in PGI-S Scores in Cohort B Participants With an ISWT at Least 1 h Following Completion of Previous ISWT (Period 2) on Day 1 | Baseline, At least 1 h following completion of previous ISWT (Period 2) on Day 1 | A global index that consists of 3 questions to which participants will rate the severity of 1) their PAH symptoms, 2) SOB, and 3) fatigue. The minimum and maximum range of scores for each of the 3 individual questions was 1-5, with severity scale choices of 1=Not present, 2=Mild, 3=Moderate, 4=Severe, and 5=Very Severe. A higher score indicated worse outcome. The Baseline is defined as the average respective severity rating measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing severity rating measured pre-ISWT, the other non-missing single severity rating would be used as baseline value. Only participants with both a measurement at baseline and at the given post-baseline visit are summarized. Change from Baseline = Post-Baseline value - Baseline value. |
| Secondary | Change From Baseline in Modified Borg Dyspnea Scores at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | The modified Borg scale allows participants to rate maximum level of dyspnea experienced during 6-Minute Walk Test (6MWT). Scores ranged from 0 (best condition) to 10 (worst condition). Baseline defined as average from Borg Dyspnea Scores measured at 15 and 0 m prior to ISWT. If a single pre-ISWT Borg Dyspnea Score was missing, the other nonmissing single score was used as baseline value. Change from Baseline=Post-Baseline value - Baseline value. Data for participants in Cohort A with an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Data for participants in Cohort B with an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are highest and lowest concentrations of a drug in plasma. |
| Other | Change From Baseline in Pulse Oximetry at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | Pulse Oximetry includes the collection of saturation peripheral capillary oxygenation (SpO\_2). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the ISWT. In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma. |
| Other | Change From Baseline in Heart Rate at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | Heart rate was captured as beats per minute (bpm). Baseline was defined as the average from pulse oximetry measured at 15 minutes and 0 minute prior to the Incremental Shuttle Walk Test (ISWT). In the case of a single, missing pre-ISWT pulse oximetry, the other non-missing single measurement would be used as baseline value. Change from Baseline = Post-Baseline value - Baseline value. Data for participants in Cohort A who had an ISWT initiated at 30 m of previous dose (expected peak level) and an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 are presented. Additionally, data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) and with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) on Day 1 are presented. Peak and trough levels are the highest and lowest concentrations of a drug in plasma. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Baseline, Approximately 30 m of previous dose of inhaled treprostinil (the expected peak level) on Day 1 | All Participants: Participants who consented to the study protocol. Data for participants in Cohort A who included an ISWT initiated at 30 m of previous dose (expected peak level) are presented. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Baseline, Approximately 3-4 h of previous dose of inhaled treprostinil (the expected trough level) on Day 1 | All Participants: Participants who consented to the study protocol. Data for participants in Cohort A who included an ISWT initiated at 3-4 h of previous dose of inhaled treprostinil (expected trough level) are presented. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline in PGI-S Score in Cohort B Participants at Approximately 4 Hours After Morning Dose of Non-Treprostinil PAH Medication (Period 1) on Day 1 | Baseline, Approximately 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 | All Participants: Participants who consented to the study protocol. Data for participants in Cohort B who included an ISWT initiated at 4 h after morning dose of non-treprostinil PAH medication (Period 1) on Day 1 are presented. | scores on a scale | MEAN |
| PRIMARY | Change From Baseline in PGI-S Scores in Cohort B Participants With an ISWT at Least 1 h Following Completion of Previous ISWT (Period 2) on Day 1 | Baseline, At least 1 h following completion of previous ISWT (Period 2) on Day 1 | All Participants: Participants who consented to the study protocol. Data for participants in Cohort B with an ISWT initiated at least 1 h following completion of previous ISWT (Period 2) are presented. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Borg Dyspnea Scores at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | All Participants: Participants who consented to the study protocol. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint. | scores on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Pulse Oximetry at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | All Participants: Participants who consented to the study protocol. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint | percent saturation (SpO_2) | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Heart Rate at Day 1 | Baseline, ~30 m of previous dose of inhaled treprostinil, ~3-4 h of previous dose of inhaled treprostinil, ~4 h after morning dose of non-treprostinil PAH medication, and ≥1 h following completion of previous ISWT on Day 1 | All Participants: Participants who consented to the study protocol. Here, 'Number Analyzed' signifies participants evaluable at the specified timepoint | bpm | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | PAH, Baseline | 1.25 | Standard Deviation 0.47 | scores on a scale |
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | PAH, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.65 | Standard Deviation 0.80 | scores on a scale |
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | SOB, Baseline | 1.15 | Standard Deviation 0.33 | scores on a scale |
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | SOB, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.90 | Standard Deviation 0.80 | scores on a scale |
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | Fatigue, Baseline | 1.30 | Standard Deviation 0.55 | scores on a scale |
Change From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1 | Cohort A: Treprostinil | Fatigue, Change at 30 m of previous dose of inhaled treprostinil (expected peak level) on Day 1 | 1.40 | Standard Deviation 0.95 | scores on a scale |
| Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Cohort A: Treprostinil | PAH, Baseline | 1.10 | Standard Deviation 0.31 | scores on a scale |
| Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Cohort A: Treprostinil | PAH, Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 1.75 | Standard Deviation 0.79 | scores on a scale |
| Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Cohort A: Treprostinil | SOB, Baseline | 1.10 | Standard Deviation 0.31 | scores on a scale |
| Change From Baseline in PGI-S Score in Cohort A Participants at Approximately 3-4 Hours of Previous Dose of Inhaled Treprostinil (the Expected Trough Level) on Day 1 | Cohort A: Treprostinil | SOB, Change at 3-4 h of previous dose of inhaled treprostinil (expected trough level) on Day 1 | 1.85 | Standard Deviation 0.93 | scores on a scale |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cohort A Peak Level/Cohort B Period 1 | STARTED | Cohort A: Treprostinil | 20 | |
| Cohort A Peak Level/Cohort B Period 1 | STARTED | Cohort B: Non-Treprostinil PAH Medications | 23 | |
| Cohort A Peak Level/Cohort B Period 1 | Safety Population | Cohort A: Treprostinil | 20 | |
| Cohort A Peak Level/Cohort B Period 1 | Safety Population | Cohort B: Non-Treprostinil PAH Medications | 23 | |
| Cohort A Peak Level/Cohort B Period 1 | COMPLETED | Cohort A: Treprostinil | 20 | |
| Cohort A Peak Level/Cohort B Period 1 | COMPLETED | Cohort B: Non-Treprostinil PAH Medications | 23 | |
| Cohort A Peak Level/Cohort B Period 1 | NOT COMPLETED | Cohort A: Treprostinil | 0 | |
| Cohort A Peak Level/Cohort B Period 1 | NOT COMPLETED | Cohort B: Non-Treprostinil PAH Medications | 0 | |
| Rest - At Least 1 h | STARTED | Cohort A: Treprostinil | 20 | |
| Rest - At Least 1 h | STARTED | Cohort B: Non-Treprostinil PAH Medications | 23 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events16
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 | Diarrhoea | Gastrointestinal disorders | Cohort A: Treprostinil | 0 | 20 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort B: Non-Treprostinil PAH Medications | 1 | 23 | |
| other | Vomiting | Gastrointestinal disorders | Cohort A: Treprostinil | 0 | 20 | |
| other | Vomiting | Gastrointestinal disorders | Cohort B: Non-Treprostinil PAH Medications | 1 | 23 | |
| other | Chills | General disorders | Cohort A: Treprostinil | 0 | 20 | |
| other | Chills | General disorders | Cohort B: Non-Treprostinil PAH Medications | 1 | 23 | |
| other | Fatigue | General disorders | Cohort A: Treprostinil | 0 | 20 | |
| other | Fatigue | General disorders | Cohort B: Non-Treprostinil PAH Medications | 1 | 23 | |
| other | Non-cardiac chest pain | General disorders | Cohort A: Treprostinil | 0 | 20 | |
| other | Non-cardiac chest pain | General disorders | Cohort B: Non-Treprostinil PAH Medications | 1 | 23 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Treprostinil | 0 | 20 |
| Total, all-cause mortality | Cohort B: Non-Treprostinil PAH Medications | 0 | 23 |
| Total, other adverse events | Cohort A: Treprostinil | 0 | 20 |
| Total, other adverse events | Cohort B: Non-Treprostinil PAH Medications | 9 | 23 |
| Total, serious adverse events | Cohort A: Treprostinil | 0 | 20 |
| Total, serious adverse events | Cohort B: Non-Treprostinil PAH Medications | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A: Treprostinil vs Cohort B: Non-Treprostinil PAH Medications: deaths from any cause | Trial comparisons |
| Cohort A: Treprostinil vs Cohort B: Non-Treprostinil PAH Medications: serious adverse events | Trial comparisons |
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/NCT03888365
GET https://conductscience.org/api/trials/v1/NCT03888365/results?page=2