Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) (PERFECT OLE)
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|ClinicalTrials.gov Identifier: NCT03794583|
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : August 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Chronic Obstructive Pulmonary Disease||Drug: Inhaled treprostinil solution||Phase 3|
This is a multi-center, open-label study for eligible participants who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.
Participants who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.
All participants will reinitiate inhaled treprostinil at 3 breathes (18 micrograms [mcg]) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing regimen of 15 breaths QID or the maximum tolerated dose.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||July 31, 2025|
|Estimated Study Completion Date :||July 31, 2025|
Experimental: Inhaled Treprostinil Solution
Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours.
Drug: Inhaled treprostinil solution
Inhaled treprostinil solution per dose and schedule specified in the arm
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From enrollment to end of study, estimated up to 2 years. ]
- 6 Minute Walk Distance (6MWD) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]Participants will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.
- Borg Dyspnea Score [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]The modified 0-10 category-ratio Borg scale is one in which the participants rate the maximum level of dyspnea they experienced during the Six Minute Walk Test (6MWT). Scores range from 0 (for the best condition) and 10 (for the worst condition).
- N-terminal Pro-brain Natriuretic Peptide (NT-pro-BNP) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.
- Saturation Peripheral Capillary Oxygenation (SpO2) [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]SpO2 will be assessed via pulse oximetry.
- Heart Rate [ Time Frame: Assessed at enrollment, Week 6, and then every 12 weeks through study completion, estimated up to 2 years. ]Heart rate will be assessed via pulse oximetry
- Change in Baseline in Patient Global Assessment (PGA) [ Time Frame: Week 6, Year 1 or Discontinuation Visit (whichever occurs first) ]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.
- Change from Baseline in Actigraphy [ Time Frame: Baseline, Week 6, Year 1 or Discontinuation Visit (whichever occurs first) ]Daily physical activity, including overall, non-sedentary, and moderate to vigorous physical activity will be measured via a wrist-worn medical grade physical activity monitor (actigraph).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794583