A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participa… (NCT03496623) | Clinical Trial Compass
TerminatedPhase 3
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)
Stopped: Sponsor's decision
United States188 participantsStarted 2018-05-08
Plain-language summary
The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant voluntarily gives informed consent to participate in the study.
✓. Males and females 18 years of age and above at the time of informed consent.
✓. 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, \[\<1% per year\], 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. Participants must have a negative pregnancy test at the Screening Visit 1 (urine \[prior to the first dose of study medication\] and serum) and Baseline Visit (Study Week 1) (urine).
✓. 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.
✓. Diagnosis of PH-COPD (World Heath Organization \[WHO\] Group 3).
✓. Clinical diagnosis of COPD will be made using the Global Initiative for Chronic
✓. Forced expiratory volume in 1 second (FEV1) \<80% predicted
✓
What they're measuring
1
Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD)
✕. The participant has a diagnosis of either pulmonary arterial hypertension (PAH) or pulmonary hypertension (PH) due to reasons other than COPD. This would include, but is not limited to, chronic thromboembolic PH or acute/recent deep vein thrombosis or pulmonary embolism, untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma or systemic lupus erythematosus), sarcoidosis, human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
✕. Based on chest computed tomography (CT) imaging during Screening Visit 1, the participant has a confirmed diagnosis of WHO Group 3 PH, other than COPD, such as idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease or interstitial lung disease. A previous chest CT scan performed within the 6 months prior to the start of Screening Visit 1 is also acceptable, and a repeat assessment is not required.
✕. The participant has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (that is, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist \[ERA\], phosphodiesterase type 5 inhibitor \[PDE5-I\], or soluble guanylate cyclase \[sGC\] stimulator) at Screening Visit 1 and thereafter, except if received for acute vasoreactivity testing.
✕. The participant has a previous diagnosis of homozygous alpha-1 antitrypsin deficiency.
✕. The participant has any prior intolerance to inhaled prostanoid therapy.
✕. Inability to tolerate low-dose (3 breaths, 18 mcg) study drug and/or inability to follow dosing regimen during the Screening Period (pre-randomization).
✕. Unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
✕. The participant has evidence of clinically significant left-sided heart disease (including but not limited to left ventricular ejection fraction \<40%, left ventricular hypertrophy,) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor Medical Monitor is needed.