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

NCT03012646 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: RIN-PH-203
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease

Keywords

Treprostinil; PH; COPD; 6 Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in 6-minute Walk Distance (6MWD) 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

• Change in Forced Expiratory Volume (FEV1) in One Second 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 Lung Diffusion Capacity (DLCO) from Baseline to Week 48

  Baseline and Week 48

Study Arms (1)

Active Inhaled Treprostinil

EXPERIMENTAL

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

Drug: Inhaled Treprostinil

Interventions

Inhaled Treprostinil DRUG

Inhaled treprostinil (6 mcg/breath) administered four times daily

Also known as: Tyvaso

Active Inhaled Treprostinil

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of WHO Group 3 PH associated with COPD
• 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:
• Pulmonary vascular resistance (PVR) ≥ 4 Wood Units (WU) and
• 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
• A mean pulmonary arterial pressure (mPAP) of ≥ 30 mmHg
• 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:
• FEV1 \< 65% predicted, and
• FEV1/ FVC \< 70
• Baseline 6MWD ≥ 100 meters

You may not qualify if:

• 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.
• The subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment:
• 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)
• Left ventricular ejection fraction \<40% as assessed by either angiography or echocardiography.

Sponsors & Collaborators

• United Therapeutics: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Interventions

treprostinil

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 6, 2017
• Study Start: April 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 11, 2017

Record last verified: 2017-04