Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

1. 6MWD \<150 meters during Screening

2. DLCO ≤25% during Screening

3. Pregnant or lactating

4. Known intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy

5. Confirmed diagnosis of PAH or PH for any reason other than associated with COPD

6. Received any PAH-approved therapy within 60 days prior to Baseline. As needed (PRN) use of a PDE5-I (eg, sildenafil, tadalafil, vardenafil) for erectile dysfunction is permitted. Daily use of a PDE5-I, even if for an indication other than PH, is not allowed.

7. Unable or unwilling to use Sponsor-provided devices (eg, SMI)

8. Confirmed diagnosis of idiopathic pulmonary fibrosis, combined pulmonary fibrosis and emphysema, diffuse parenchymal lung disease, or interstitial lung disease. Redacted computed tomography scan results conducted within 6 months prior to Baseline must be provided to the Sponsor's Medical Monitor with the Pre Baseline Form to confirm eligibility.

9. Previous diagnosis of homozygous alpha-1 antitrypsin deficiency

10. Myocardial infarction within 6 months prior to Baseline or unstable angina within 30 days prior to Baseline

11. Evidence of clinically significant left-sided heart disease (including, but not limited to, left ventricular ejection fraction \<40% and/or left ventricular hypertrophy) or clinically significant cardiologic conditions, such as congestive heart failure, coronary artery disease, or valvular heart disease. Note: Participants with abnormal left ventricular function attributable to the effects of right ventricular overload will not be excluded, but a discussion with and approval by the Sponsor's Medical Monitor is required.

12. Any form of congenital heart disease (repaired or unrepaired) other than a patent foramen ovale

13. Recent exacerbation of COPD and/or active pulmonary or upper respiratory infection that required hospitalization, symptomatic treatment, or treatment with antibiotics and/or corticosteroids:

1. If hospitalized, within 180 days prior to Baseline

2. If not hospitalized, within 90 days prior to Baseline

14. Initiation of pulmonary rehabilitation within 12 weeks prior to Baseline or, in the opinion of the Investigator, pulmonary rehabilitation is likely to be needed during the Treatment Period

15. Use of any other investigational drug/device or participation in any investigational study in which the participant received a medical intervention (ie, procedure, device, medication/supplement) within 30 days prior to Baseline. Participation in non-interventional, observational, or registry studies is permitted.

16. In the opinion of the Investigator, the participant has any condition that would interfere with the interpretation of study assessments, study participation or cooperation, or has any disease or condition (ie, peripheral vascular disease, musculoskeletal disorder, morbid obesity) that would likely be the primary limit to ambulation (as opposed to PH)

Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

What this study is about

Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)

What this study is about