CompletedPhase 3

Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil

United States121 participantsStarted 2018-01-02

Plain-language summary

The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Idiopathic PAH (1.1), or
✓. Heritable PAH (1.2), or
✓. Drug and toxin induced PAH (1.3), or
✓. PAH associated with connective tissue disease (1.4.1), HIV infection (1.4.2), or congenital heart disease (1.4.4) with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
✓. has documented stable doses of approved inhaled therapy for at least 3 months prior to screening and is willing and able to transition from their prescribed dose of inhaled therapy to study drug, or
✓. has documented stable doses of no more than two approved oral therapies for at least 3 months prior to screening and is willing and able to add LIQ861 to their treatment regimen.

What they're measuring

Incidence of Treatment-Emergent Adverse Events and Serious Adverse Events

Timeframe: Baseline, Week 2, Month 1, Month 2 Visits, with bimonthly follow up for up to 16 months.

Trial details

NCT IDNCT03399604

SponsorLiquidia Technologies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-06

Results submitted2024-03-13

View on ClinicalTrials.gov More Primary Pulmonary Hypertension trials