Back to results

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

Primary Purpose

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Inhaled Treprostinil

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Treprostinil, PH, COPD, 6 Minute Walk Test

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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
Baseline 6MWD ≥ 100 meters

Exclusion criteria:

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.
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:
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Inhaled Treprostinil

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48

Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48

Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48

Change in Forced Vital Capacity (FVC) from Baseline to Week 48

Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48

Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48

Full Information

NCT ID

NCT03012646

First Posted

December 22, 2016

Last Updated

April 7, 2017

Sponsor

United Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03012646

Brief Title

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

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Business decision

Study Start Date

April 2017 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease

Keywords

Treprostinil, PH, COPD, 6 Minute Walk Test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Inhaled Treprostinil

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled Treprostinil

Other Intervention Name(s)

Tyvaso

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of Adverse Events Among Participants through 48 Weeks

Description

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Change in 6-minute Walk Distance (6MWD) from Baseline to Week 48

Time Frame

Baseline and Week 48

Title

Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to Week 48

Time Frame

Baseline and Week 48

Title

Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48

Time Frame

Baseline and Week 48

Title

Change in Forced Vital Capacity (FVC) from Baseline to Week 48

Time Frame

Baseline and Week 48

Title

Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48

Time Frame

Baseline and Week 48

Title

Change in right ventricular ejection fraction (RVEF) as assessed via cMRI from Baseline to Week 48

Time Frame

Baseline and Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion criteria: 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. 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.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs