Clinical trial NCT03012646: Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD
Official title: A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Tolerability of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Keywords: Treprostinil
PH
COPD
6 Minute Walk Test
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of WHO Group 3 PH associated with COPD
2. Subjects are required to have a right heart catheterization (RHC) within one year prior to the first dose of study drug with the following parameters:

   1. Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
   2. A left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤ 12 mmHg if PVR ≥ 4 WU to \< 6.25 WU or ≤ 15 mmHg if PVR ≥ 6.25 WU and
   3. A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
3. Clinical Diagnosis of COPD will be made using accepted Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria, including Baseline spirometry with the following documented parameters:

   1. FEV1 \< 65% predicted, and
   2. FEV1/ FVC \< 70
4. Baseline 6MWD ≥ 100 meters

Exclusion criteria:

1. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than COPD as outlined in inclusion criterion 3. This would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under WHO Group 1, 2, 4, and 5 classifications.
2. The subject has received any Food and Drug Administration (FDA)-approved medication for the treatment of PAH (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist \[ERA\], phosphodiesterase type 5 inhibitor \[PDE5-I\],or soluble guanylate cyclase \[sGC\] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing.
3. The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:

   1. Left ventricular end diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) \>15 mmHg (or \>12 mmHg if pulmonary vascular resistance \[PVR\] ≥4 to \<6.25 WU)
   2. Left ventricular ejection fraction \<40% as assessed by either angiography or echocardiography.

Primary outcomes:
measure: Incidence of Adverse Events Among Participants through 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in Forced Vital Capacity (FVC) from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48
timeFrame: Baseline and Week 48
measure: Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
Study officials:
References: