Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD

Phase 2

Withdrawn

• Conditions: Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Inhaled Treprostinil

• Registration Number: NCT03012646
• Lead Sponsor: United Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Status Verified: 2017-04
• Study Start: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active Inhaled Treprostinil	Inhaled Treprostinil	Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events Among Participants through 48 Weeks	48 weeks	The incidence of adverse events among participants throughout the 48-week study will be measured by the number of participants analyzed and the percentage of those participants who experienced an adverse event.

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48	Baseline and Week 48
Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48	Baseline and Week 48
Change in Forced Vital Capacity (FVC) from Baseline to Week 48	Baseline and Week 48
Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48	Baseline and Week 48
Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48	Baseline and Week 48
Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48	Baseline and Week 48