Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE (NCT02630316) | Clinical Trial Compass
CompletedPhase 2/3
Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE
United States326 participantsStarted 2017-02-03
Plain-language summary
This was a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study included 326 patients at approximately 120 clinical trial centers. The treatment phase of the study lasted approximately 16 weeks. Patients who completed all required assessments were eligible to enter an open-label, extension study (RIN-PH-202).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject voluntarily gave informed consent to participate in the study.
✓. Males and females aged 18 years or older at the time of informed consent.
✓. The subject had a confirmed diagnosis of WHO Group 3 PH based on computed tomography (CT) imaging which was performed within 6 months prior to randomization and demonstrated evidence of diffuse parenchymal lung disease. Subjects had any form of ILD or CPFE.
✓. Subjects were required to have a right heart catheterization (RHC) within 1 year prior to randomization with the following documented parameters:
✓. Pulmonary vascular resistance (PVR) \>3 Wood Units (WU) and
✓. A pulmonary capillary wedge pressure (PCWP) of \<15 mmHg and
✓. A mean pulmonary arterial pressure (mPAP) of \>25 mmHg
✓. Baseline 6MWD ≥100 m.
Exclusion criteria
✕. The subject had a diagnosis of PAH or PH for reasons other than WHO Group 3 PH ILD as outlined in Inclusion Criterion 3.
What they're measuring
1
Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 16
✕. The subject showed intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
✕. The subject received any PAH-approved therapy including: prostacyclin therapy (ie, epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), prostacyclin (IP) receptor agonist (selexipag), endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE5-I), or soluble guanylate cyclase (sGC) stimulator within 60 days of randomization.
✕. The subject had evidence of clinically significant left-sided heart disease as defined by:
✕. PCWP \>15 mmHg
✕. Left ventricular ejection fraction \<40%. Note: Subjects with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (ie, right ventricular hypertrophy and/or dilatation) were not excluded.
✕. The subject was receiving \>10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.
✕. Current use of any inhaled tobacco/marijuana products or significant history of drug abuse at the time of informed consent.