WithdrawnPhase 2

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

Stopped: Business decision

0Started 2017-04

Plain-language 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).

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events Among Participants through 48 Weeks

Timeframe: 48 weeks

Trial details

NCT IDNCT03012646

SponsorUnited Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04

View on ClinicalTrials.gov More Pulmonary Hypertension trials