Clinical trial NCT03794583: Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Official title: An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Keywords: Treprostinil
Lung Diseases
Hypertension
Vascular Diseases
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Lung Biotechnology PBC
First posted: 2019-01-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.
Primary purpose: TREATMENT

Brief summary: This open-label study will evaluate the safety of continued therapy with inhaled treprostinil in participants who have completed Study RIN-PH-304 (NCT03496623). This study hypothesizes that long-term safety findings will be similar to those observed in the randomized, placebo-controlled, double-blind, adaptive study 'A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)(RIN-PH-304).

Detailed description: This is a multi-center, open-label study for eligible participants who completed all scheduled study visits during the Treatment Period of Study RIN-PH-304.

Participants who provide informed consent for this open-label extension study on or prior to the final study visit of RIN-PH-304 may participate in the study, provided all other eligibility criteria are met. The RIN-PH-304 final study visit and the RIN-PH-305 Enrollment Visit will occur on the same day.

All participants will reinitiate inhaled treprostinil at 3 breathes (18 micrograms \[mcg\]) 4 times daily (QID) during waking hours. Study drug doses should be maximized to tolerability throughout the study, and dose titrations should occur as rapidly as possible (as directed by the Investigator) with a target dosing regimen of 15 breaths QID or the maximum tolerated dose.

Eligibility criteria: Inclusion Criteria:

1. Participant voluntarily gives informed consent to participate in the study.
2. Participant completed Study RIN-PH-304.
3. Women of childbearing potential (defined as less than 1 year post-menopausal and not surgically sterile) must agree to practice abstinence or use 2 highly effective methods of contraception (defined as a method of birth control that results in a low failure rate, \[less than 1% per year\], such as approved hormonal contraceptives, barrier methods \[such as condom or diaphragm\] used with a spermicide, or an intrauterine device) for the duration of study treatment and for 48 hours after discontinuing study drug.
4. Males with a partner of childbearing potential must agree to use a barrier method (condom) with a spermicide for the duration of treatment and for at least 48 hours after discontinuing study drug.

Exclusion Criteria:

1. The participant is pregnant or lactating.
2. The participant was prematurely discontinued from Study RIN-PH-304.
3. The participant is intolerant to inhaled prostanoid therapy.
4. The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
5. The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
6. Any other clinically significant illness or abnormal laboratory value(s) that, in the opinion of the Investigator, might adversely affect the interpretation of the study data.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 4 years
Secondary outcomes:
measure: Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 6 in Borg Dyspnea Score
timeFrame: Baseline, Week 6
measure: Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy & Lung Institute
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Lung, Sleep, and Criticial Care Specialists
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Atlanta
country: United States
facility: Pulmonary & Critical Care of Atlanta
state: Georgia
city: Austell
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cincinnati
country: United States
facility: The Carl and Edyth Lindner Research Center at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Centre
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Hospital
city: Petah Tiva
country: Israel
facility: Rabin Medical Center
Study officials:
References: