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)
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|ClinicalTrials.gov Identifier: NCT03496623|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : May 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Chronic Obstructive Pulmonary Disease||Drug: Inhaled treprostinil solution Drug: Placebo solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||314 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)|
|Actual Study Start Date :||June 27, 2018|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
Experimental: Inhaled Treprostinil
Inhaled treprostinil delivered via an ultrasonic nebulizer with a target dosing regimen of 12 breaths (72 micrograms [mcg]) 4 times daily (QID)
Drug: Inhaled treprostinil solution
Treprostinil inhalation solution
Placebo Comparator: Placebo
Placebo delivered via an ultrasonic nebulizer for QID administration
Drug: Placebo solution
- Change from Baseline to Week 12 in 6MWD at Peak Exposure (10 to 60 minutes after Dosing) [ Time Frame: Baseline, Week 12 ]The intent of the 6-Minute Walk Test (6MWT) is a validated and reliable measure of exercise ability in participants with chronic respiratory diseases.
- Change from Baseline to Week 12 in Moderate to Vigorous Physical Activity (MVPA) [ Time Frame: Baseline, Week 12 ]MVPA measured by actigraphy
- Change from Baseline to Week 12 in Overall Activity [ Time Frame: Baseline, Week 12 ]Activity measured by actigraphy
- Change from Baseline to Week 12 in Borg Dyspnea Score [ Time Frame: Baseline, Week 12 ]The Borg dyspnea score is a 10 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).
- Change from Baseline to Week 12 in 6MWD/Borg Dyspnea Composite Score [ Time Frame: Baseline, Week 12 ]
- Change from Baseline to Week 12 in Quality of Life (QOL) Measured by St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, Week 12 ]The SGRQ is a designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
- Change from Baseline to Week 12 in QOL measured by the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) [ Time Frame: 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"
- Change from Baseline to Week 12 in Plasma Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Levels [ Time Frame: Baseline, Week 12 ]The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.
- Change from Baseline to Week 12 in Patient Global Assessment (PGA) [ Time Frame: 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.
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): NCT03496623
|Contact: Prakash Sista, Ph.D.||email@example.com|
|Contact: Mary Lou Tomson, M.A.||firstname.lastname@example.org|