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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03012646
• Other study ID #: RIN-PH-203
• Status: Withdrawn
• Phase: Phase 2
• First received: December 22, 2016
• Last updated: April 7, 2017
• Start date: April 2017
• Est. completion date: April 2019

Study information

• Verified date: April 2017
• Source: United Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypertension
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered four times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
United Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events Among Participants through 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.	48 weeks
Secondary	Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48		Baseline and Week 48
Secondary	Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48		Baseline and Week 48
Secondary	Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48		Baseline and Week 48
Secondary	Change in Forced Vital Capacity (FVC) from Baseline to Week 48		Baseline and Week 48
Secondary	Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48		Baseline and Week 48
Secondary	Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48		Baseline and Week 48