A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients With PH Due to COPD
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|ClinicalTrials.gov Identifier: NCT03496623|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : February 13, 2020
|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 :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Inhaled Treprostinil
Inhaled treprostinil delivered via an ultrasonic nebulizer with a target dosing regimen of 12 breaths (72 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 in 6-Minute Walk Distance (6MWD) from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]The intent of the 6-Minute Walk Test (6MWT) is a validated and reliable measure of exercise ability in patients with chronic respiratory diseases.
- Change in Borg dyspnea score from Baseline to Week 12 [ Time Frame: Baseline to 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 in quality of life (QOL) measured by St. George's Respiratory Questionnaire (SGRQ) from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]The SGRQ is a designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
- Change in QOL measured by the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) from Baseline to Week 12 [ Time Frame: Baseline to 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 in plasma concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) levels from Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function.
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.||firstname.lastname@example.org|
|Contact: Mary Lou Tomson, M.A.||email@example.com|