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Prostacyclin Analogue

Inhaled treprostinil solution for Pulmonary Hypertension (PERFECT OLE Trial)

Phase 3
Waitlist Available
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

PERFECT OLE Trial Summary

This trial will study the long-term effects of inhaled treprostinil in patients with pulmonary hypertension due to chronic obstructive pulmonary disease.

Eligible Conditions
  • Pulmonary Hypertension
  • Chronic Obstructive Pulmonary Disease

PERFECT OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Change From Baseline to Week 6 in 6-Minute Walk Distance (6MWD)
Change From Baseline to Week 6 in Borg Dyspnea Score
Change From Baseline to Week 6 in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

PERFECT OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: Inhaled Treprostinil SolutionExperimental Treatment1 Intervention
Inhaled treprostinil solution (0.6 milligrams per milliliter [mg/mL], 6 mcg/breath) QID during waking hours.

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
107 Previous Clinical Trials
13,346 Total Patients Enrolled
Lung Biotechnology PBCIndustry Sponsor
13 Previous Clinical Trials
670 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a new clinical trial?

"At this moment, there are 9 ongoing clinical trials for Inhaled treprostinil solution in 101 different cities and 6 nations. The first ever such study was completed in 2015, 70 people took part in it, and United Therapeutics sponsored the project. 46 more trials have been completed since then."

Answered by AI

What are the primary health concerns that Inhaled treprostinil solution has shown to be effective against?

"Inhaled treprostinil solution can be used to mitigate the effects of nyha functional class iii pulmonary arterial hypertension, as well as general NYHA functional class III and pulmonary arterial hypertension."

Answered by AI

Are there other examples where inhaled treprostinil solution has been used?

"There are a total of 9 ongoing clinical trials researching the effectiveness of inhaled treprostinil solution. 4 of those trials have reached Phase 3. Many of the trial locations for this treatment are based in Little Rock, Arkansas, but there are 234 centres running these tests in total."

Answered by AI

Are people with the specific ailment needed for this test program currently being accepted?

"According to the information available on clinicaltrials.gov, this particular trial is not currently looking for new patients. The study was first posted on December 21st, 2018 and was last edited October 7th, 2022. Although this study isn't recruiting right now, there are 1277 other trials that are actively seeking participants."

Answered by AI

How many people total will be taking part in this research?

"Presently, this study is not looking for more participants as it has already closed recruitment. Originally appearing on December 21st 2018 with the latest edits taking place on October 7th 2022, those affected by hypertension or pulmonary problems have 1268 and 9 other trials to respectively choose from."

Answered by AI

Are there other research hospitals participating in this study within the state?

"At the moment, this clinical trial is looking for patients from a total of 27 different hospitals. While some of these sites are in Atlanta, Chicago or Miami, there are also many other locations across the country. If you enroll in this program, it will be most convenient if you choose a clinic that is near to where you live to avoid having to travel too far."

Answered by AI

Are there any health risks associated with inhaling treprostinil solution?

"There is existing clinical evidence to support the safety of inhaled treprostinil solution, so it was given a score of 3."

Answered by AI
~6 spots leftby Apr 2025