Treprostinil inhalation powder for PAH patients switching from selexipag

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial evaluates LIQ861, a dry powder inhaler formulation of treprostinil, in adults with WHO Group 1 PAH who switch from selexipag. All participants will discontinue selexipag and begin LIQ861 four times daily for 16 weeks, with possible dose adjustments for tolerability. The study will assess safety and tolerability, and explore effects on 6-minute walk distance, a biomarker of cardiac stress, and patient-reported symptoms. Eligible participants may be on up to two other non-prostacyclin PAH medications at stable doses. The trial is conducted at a single site in Georgia, led by Liquidia Technologies as sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female 18 to 80 years of age
* Documented findings on right heart catheterization consistent with a diagnosis of WHO Group 1 pulmonary arterial hypertension of one of the following subtypes: idiopathic PAH; heritable PAH; drug- or toxin-induced PAH; PAH associated with connective tissue disease; or PAH associated with simple congenital systemic-to-pulmonary shunts repaired at least 1 year previously
* Receiving selexipag at any dose between 200 and 1600 mcg twice daily for at least 90 days, and willing and able to transition from selexipag to LIQ861 due to unsatisfactory clinical response or tolerability issues
* May be receiving up to 2 additional approved non-prostacyclin oral PAH therapies at a stable dose and regimen, planned to continue unchanged for the duration of the study
* New York Heart Association Functional Class II or III
* Able to demonstrate correct use of the dry powder inhaler

Exclusion Criteria:

* Pulmonary hypertension in WHO Group 2, 3, 4, or 5, or a WHO Group 1 subtype not listed in the inclusion criteria
* Clinically significant left-sided heart disease by echocardiography, including left ventricular ejection fraction ≤ 45%, left atrial volume index \> 48 mL/m², or hemodynamically significant valvular disease
* Symptomatic coronary artery disease within the previous 6 months
* Prior atrial septostomy

Where it's running

• Southeastern Cardiology Associates
  Columbus, Georgia, United States Recruiting

Study contacts

• Study coordinator: Liquidia Point of Contact
• Email: LiquidiaStudies@liquidia.com
• Phone: 1-888-241-6906

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sleep problems in PAH patients: how sleep breathing relates to PAH outcomes

  This study tests how sleep-disordered breathing and nocturnal oxygen changes relate to outcomes in adults with pulmonary arterial hypertension.

  Recruiting Chinese Pulmonary Vascular Disease Research Group · Beijing · NCT07852403

• Impact of ambient air vs nasal liquid oxygen on exercise performance in pulmonary vascular disease

  This study tests whether using nasal liquid oxygen during a 6-minute walk test changes how far patients with PAH or CTEPH can walk compared to breathing room air.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07777445

• Liquid oxygen vs ambient air during a 6-minute walk in people with pulmonary vascular disease

  This study tests whether walking with liquid oxygen at about 4 L/min helps or hinders distance walked compared with walking on room air in adults with PAH or CTEPH living in Switzerland.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07777367

• Escalation options for PAH patients already on dual therapy

  This trial tests whether adding a prostacyclin pathway drug or increasing sildenafil dose helps PAH patients at intermediate-to-high risk who aren’t at low risk despite dual therapy.

  Recruiting Phase 4 University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07713914

• Vasoactive Agents in Pulmonary Hypertension Crisis

  This trial tests whether dopamine, norepinephrine, or epinephrine can safely and effectively help people with a pulmonary hypertension crisis who are in the hospital.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality and 2 other locations · NCT07667829

• Tele-Pulmonary Rehabilitation for Chronic Lung Diseases

  This study tests whether a remote tele-rehabilitation program helps people with chronic lung diseases start and stick with pulmonary rehab better than usual center-based care.

  Recruiting at 2 sites Tel-Aviv Sourasky Medical Center · Ashkelon and 1 other locations · NCT07666841

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.