Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03888365
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2019-03-18
Brief Title:
Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
An Observational Study to Characterize Patient Global Impression Questions for Activity-induced Symptoms in Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRN
Brief Summary:
This is an observational multicenter single-day Phase 2 study This study will include a 14-day Screening Period and Study Day 1 clinic visit Participants will be required to perform an activity to induce symptoms of PAH and participants severity of self-reported symptoms of PAH will be measured from pre-activity immediately after the activity and through the 30-minute recovery Participants will be asked about their PAH symptoms using 3 PGI-S questions that address their overall PAH symptoms shortness of breath and physical fatigue
Detailed Description:
This is an observational multicenter single-day Phase 2 study This study will include a 14-day Screening Period and Study Day 1 clinic visit Participants will be required to perform an activity to induce symptoms of PAH and participants severity of self-reported symptoms of PAH will be measured from pre-activity immediately after the activity and through the 30-minute recovery Participants will be asked about their PAH symptoms using 3 Patient Global Impression of Severity PGI-S questions that address their overall PAH symptoms shortness of breath and physical fatigue
PAH symptoms will be induced via the Incremental Shuttle Walk Test ISWT The ISWT used in this study required the participant to walk back and forth on a 10-meter course The total number of shuttles completed by a participant during the Screening ISWT will be the maximum targeted for that participant during the remaining ISWTs in the study
After Screening participants will be assigned to 1 of 2 cohorts based on PAH medications as prescribed by their physician Cohort A will include participants who are currently prescribed and using inhaled treprostinil for the treatment of PAH and Cohort B will include participants who are taking other PAH medications instead of inhaled treprostinil
The study also includes 2 periods One period for participants in Cohort A Treprostinil Users included an ISWT initiated within 30 minutes of the previous dose expected peak level and the other period included an ISWT within 3 to 4 hours of the previous dose of inhaled treprostinil expected trough level Participants in Cohort B Non-Treprostinil Users an ISWT will be initiated approximately 4 hours after the morning dose of PAH medication Period 1 and an ISWT initiated at least 1 hour following completion of the previous ISWT Period 2 Participants will be provided at least a 1-hour period for rest between ISWTs until participant feels they are rested enough to perform again at their baseline level prior to Period 2 assessments
PAH symptoms will be induced via the Incremental Shuttle Walk Test ISWT The ISWT used in this study required the participant to walk back and forth on a 10-meter course The total number of shuttles completed by a participant during the Screening ISWT will be the maximum targeted for that participant during the remaining ISWTs in the study
After Screening participants will be assigned to 1 of 2 cohorts based on PAH medications as prescribed by their physician Cohort A will include participants who are currently prescribed and using inhaled treprostinil for the treatment of PAH and Cohort B will include participants who are taking other PAH medications instead of inhaled treprostinil
The study also includes 2 periods One period for participants in Cohort A Treprostinil Users included an ISWT initiated within 30 minutes of the previous dose expected peak level and the other period included an ISWT within 3 to 4 hours of the previous dose of inhaled treprostinil expected trough level Participants in Cohort B Non-Treprostinil Users an ISWT will be initiated approximately 4 hours after the morning dose of PAH medication Period 1 and an ISWT initiated at least 1 hour following completion of the previous ISWT Period 2 Participants will be provided at least a 1-hour period for rest between ISWTs until participant feels they are rested enough to perform again at their baseline level prior to Period 2 assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None