Pulmonary HypertensionPhase 3PERFECT OLENCT03794583
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
A Phase 3 study testing Inhaled treprostinil solution in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 32 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled treprostinil solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 32 sitesin 3 countries
- Study dates
- 21 Dec 2018to 29 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant voluntarily gives informed consent to participate in the study.
- Participant completed Study RIN-PH-304.
- 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.
- 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.
Who cannot join
- The participant is pregnant or lactating.
- The participant was prematurely discontinued from Study RIN-PH-304.
- The participant is intolerant to inhaled prostanoid therapy.
- The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
- The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
- 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.
Trial locations and contacts
32 sites in 3 countries.
32 sites in 3 countries
United States28 sites
Albany Medical Center
Albany, New York, 12208
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, 30342
Georgia Clinical Research
Austell, Georgia, 30106
University of Maryland Medical Center
Baltimore, Maryland, 21201
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois Medical Center
Chicago, Illinois, 60612
The Carl and Edyth Lindner Research Center at The Christ Hospital
Cincinnati, Ohio, 45219
St. Francis Sleep Allergy & Lung Institute
Clearwater, Florida, 33765
Cleveland Clinic
Cleveland, Ohio, 44195
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49546
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260
St. Vincent's Lung, Sleep, and Criticial Care Specialists
Jacksonville, Florida, 32204
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
University of Miami Hospital
Miami, Florida, 33136
Mount Sinai Medical Center
New York, New York, 10029
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
Carilion Clinic
Roanoke, Virginia, 24014
University of Rochester Medical Center
Rochester, New York, 14623
University of California Davis Medical Center
Sacramento, California, 95817
Israel3 sites
Lady Davis Carmel Medical Centre
Haifa, 34362
Hadassah-Hebrew University Hospital
Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, 4941492
Italy1 site
"Azienda Unita Sanitaria Locale Della Romagna Ospedale ""Gian Battista Morgagni"" - Luigi Pierantoni"" di Forli"
Forlì, Forli, 47121
About this study
Official title: An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
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).
Read the 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.
- Being tested
- Inhaled treprostinil solution
- Keywords
- Treprostinil, Lung Diseases, Hypertension, Vascular Diseases
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Hypertension, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled treprostinil solutionDrug
Inhaled treprostinil solution per dose and schedule specified in the arm
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Treprostinil Solution | Experimental | Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours. Receives: Drug: Inhaled treprostinil solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent was defined as any AE occurring/worsening at any time after a participant was exposed to study drug up until 7 days after the last dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Up to 4 years
Secondary outcomes (3)
Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)
6MWD was calculated at peak exposure (10 to 60 minutes after dosing). 6-minute walk test (6MWT) was performed by standardized procedures for all participants. Participants were asked to walk a set course for 6 minutes (timed) and the distance walked (in meters) was recorded.
Measured: Baseline, Week 6
Change From Baseline to Week 6 in Borg Dyspnea Score
The Borg Dyspnea Score was a 11-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (no dyspnea at all) to 10 (very, very severe dyspnea), with lower scores indicating less exertion (a better outcome). The Borg Dyspnea Score was to be evaluated immediately after the 6MWT.
Measured: Baseline, Week 6
Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
The NT-proBNP concentration is a biomarker associated with changes in right heart morphology and function. Improvement is defined as a decrease in the NT-proBNP plasma concentration.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start21 Dec 2018
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by United TherapeuticsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lung Biotechnology PBC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794583
- Sponsor's protocol ID
- RIN-PH-305
- Acronym
- PERFECT OLE
- Status last verified
- May 2026
- First submitted
- 2 Jan 2019
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study of Inhaled Treprostinil in Patients With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)
- ClinicalTrials.gov ID
- NCT03794583
- Acronym / sponsor ID
- PERFECT OLE / RIN-PH-305
- Keywords
- Treprostinil, Lung Diseases, Hypertension, Vascular Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 41 participants (actual)
- Lead sponsor
- United TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Lung Biotechnology PBC
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 18 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is not blinded. All participants will begin titration of study drug once all entry criteria have been met.
| Arm | Type | Receives |
|---|---|---|
| Inhaled Treprostinil Solution | Experimental | Drug: Inhaled treprostinil solutionInhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant voluntarily gives informed consent to participate in the study.
- Participant completed Study RIN-PH-304.
- 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.
- 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.
Key exclusion criteria (6 listed)
- The participant is pregnant or lactating.
- The participant was prematurely discontinued from Study RIN-PH-304.
- The participant is intolerant to inhaled prostanoid therapy.
- The participant is unwilling or unable to use Sponsor-provided devices (actigraph, spirometer, or smart device).
- The participant is scheduled to receive another investigational drug, device, or therapy during the course of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled treprostinil solutionInhaled treprostinil solution per dose and schedule specified in the arm | Drug | Inhaled Treprostinil Solution |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 4 years
An adverse event (AE) can be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent was defined as any AE occurring/worsening at any time after a participant was exposed to study drug up until 7 days after the last dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
3 secondary outcomes
Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)
Time frame: Baseline, Week 6
Change From Baseline to Week 6 in Borg Dyspnea Score
Time frame: Baseline, Week 6
Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled treprostinil solution in people with Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease, run by United Therapeutics at 32 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.