Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmo… (NCT03794583) | Clinical Trial Compass
TerminatedPhase 3
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Stopped: Sponsor's decision
United States41 participantsStarted 2018-12-21
Plain-language summary
This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study '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)(RIN-PH-304).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant voluntarily gives informed consent to participate in the study.
✓. Participant completed Study RIN-PH-304.
✓. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, \[less than 1% per year\], such as approved hormonal contraceptives, barrier methods \[such as condom or diaphragm\] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
✓. Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion criteria
✕. The participant is pregnant or lactating.
✕. The participant was prematurely discontinued from Study RIN-PH-304.
✕. The participant is intolerant to inhaled prostanoid therapy.
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
. The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
✕. The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
✕. Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.