20 Participants NeededMy employer runs this trial

Inhaled Treprostinil for Pulmonary Arterial Hypertension

LP
Overseen ByLiquidia Point of Contact
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Liquidia Technologies, Inc.
Must be taking: Selexipag
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will look at safety and tolerability of LIQ861 (treprostinil) inhalation powder in adults with pulmonary arterial hypertension (PAH, WHO Group 1) who switch from selexipag, a medicine taken by mouth, to treprostinil, a medicine breathed into the lungs.

Everyone who takes part will receive LIQ861. On the first study day, participants will stop taking selexipag and begin taking LIQ861 four times a day using a small handheld dry powder inhaler. The dose may be increased over time based on how well it is tolerated. Participants will take LIQ861 for 16 weeks.

The study will also look at whether switching to LIQ861 affects walking distance, a blood marker of heart strain, and symptoms reported by participants.

Are You a Good Fit for This Trial?

This trial is for adults with pulmonary arterial hypertension (PAH, WHO Group 1) who are currently taking selexipag by mouth and are able to switch to a new inhaled medication. Participants should be stable enough to safely stop selexipag and start the study drug.

Inclusion Criteria

My heart condition limits my activity but I am comfortable at rest.
I am between 18 and 80 years old.
Able to demonstrate correct use of the dry powder inhaler
See 3 more

Exclusion Criteria

I have pulmonary hypertension that is not WHO Group 1 as required by the study.
I have serious heart problems affecting the left side of my heart.
I have had an atrial septostomy procedure before.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants transition from oral Selexipag to inhaled Treprostinil (LIQ861) and take it four times a day using a handheld dry powder inhaler. The dose may be increased over time based on tolerance.

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking distance, blood markers of heart strain, and symptoms.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LIQ861 (treprostinil) inhalation powder

Trial Overview

The study tests the safety of LIQ861, an inhaled form of treprostinil, in people with PAH who switch from oral selexipag. All participants will use a handheld dry powder inhaler four times daily for 16 weeks. The dose may be adjusted based on tolerance.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Selexipag to LIQ861 (treprostinil) inhalation powderExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Liquidia Technologies, Inc.

Lead Sponsor

Trials
7
Recruited
500+