Inhaled Treprostinil for Pulmonary Arterial Hypertension
Recruiting at 24 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Liquidia Technologies, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug LIQ861 Inhaled Treprostinil for Pulmonary Arterial Hypertension?
What makes the drug LIQ861 Inhaled Treprostinil unique for treating pulmonary arterial hypertension?
LIQ861 is a dry-powder inhaled formulation of treprostinil, which is unique because it offers a more convenient and potentially more tolerable option compared to the nebulized form of the drug. It uses PRINT® technology to create uniform drug particles, allowing for a simpler administration process and potentially reducing the frequency of inhalations needed compared to other treatments.678910
Research Team
NS
Nicholas S Hill, MD
Principal Investigator
Tufts Medical Center
Eligibility Criteria
This trial is for patients with pulmonary arterial hypertension who have previously participated in LIQ861 studies. They must understand the study, follow its procedures, and agree to use contraception if there's a risk of pregnancy. Participants should have completed prior LIQ861 study requirements or reached an endpoint.Inclusion Criteria
Evidence of a personally signed and dated informed consent document exists indicating that the patient has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures
Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Patient has fulfilled all entry criteria at the time of enrollment in original study with LIQ861
See 2 more
Exclusion Criteria
Patient prematurely discontinued LIQ861 due to a drug-related AE/SAE or tolerability issue in the original LIQ861 study in which they were enrolled, or patient did not complete protocol defined study procedures at an end of study visit (not Early Termination visit) in their original LIQ861 study
Patient withdrew consent during participation in another LIQ861 study
Any reason exists that, in the opinion of the Investigator or Medical Monitor, precludes the patient from participating in the study, e.g., any previous or intercurrent medical condition that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
See 2 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive LIQ861 inhaled treprostinil using a dry powder inhaler, with doses titrated under clinical supervision
2.5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Participants continue to receive LIQ861 to evaluate long-term safety
Long-term
Treatment Details
Interventions
- LIQ861 Inhaled Treprostinil
Trial OverviewThe focus of this extension study is on the long-term safety of inhaling a drug called Treprostinil (LIQ861) as a dry powder for treating pulmonary arterial hypertension. It continues from previous LIQ861 trials.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: LIQ861 Inhaled TreprostinilExperimental Treatment1 Intervention
LIQ861 inhaled treprostinil at capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg. LIQ861 will be administered using the RS00 Model 8 dry powder inhalation (DPI) device (Plastiape S.p.A.; Osnago, Italy) at dose levels of 25 μg capsule strength to 200 μg capsule strength treprostinil four times a day (QID) in individual patients. Titrating to dose levels beyond 200 μg capsule strength QID, under clinical investigator supervision, requires review and approval from the Medical Monitor.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Liquidia Technologies, Inc.
Lead Sponsor
Trials
7
Recruited
500+
Nuventra, Inc.
Collaborator
Trials
2
Recruited
210+
Nuventra, Inc.
Industry Sponsor
Trials
5
Recruited
340+
Findings from Research
The study established a reliable in vitro method for delivering treprostinil, a treatment for pulmonary arterial hypertension, through a ventilator circuit, achieving a controlled dose of 54 μg in just 29 seconds.
The method demonstrated that the AeroTech II nebulizer could effectively deliver aerosolized treprostinil with consistent dosing across various breathing patterns, highlighting the importance of precise nebulization conditions for optimal drug delivery.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
In vitro delivery of aerosolized treprostinil via modern mechanical ventilation.Patel, RB., Smaldone, GC., Cuccia, AD., et al.[2017]
The study found that the vibrating mesh nebulizer is an effective alternative to the Tyvaso Inhalation System for delivering inhaled treprostinil, with similar fine particle fractions and often greater inhaled mass across various age models (neonatal, pediatric, and adult).
In particular, using the vibrating mesh nebulizer with high-frequency oscillatory ventilation in neonatal and pediatric models resulted in higher delivery of treprostinil, which could lead to higher than expected dosages for these patients.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Inhaled Treprostinil Drug Delivery During Mechanical Ventilation and Spontaneous Breathing Using Two Different Nebulizers.Parker, DK., Shen, S., Zheng, J., et al.[2018]
Nebulised ensifentrine showed a clear dose-response relationship in improving lung function (FEV1) in asthma patients, outperforming placebo and demonstrating effectiveness comparable to salbutamol, a standard asthma treatment.
All doses of ensifentrine were well tolerated with no significant adverse effects on heart rate or potassium levels, unlike salbutamol, which caused dose-related reductions in potassium and increased heart rates.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy and safety of a first-in-class inhaled PDE3/4 inhibitor (ensifentrine) vs salbutamol in asthma.Bjermer, L., Abbott-Banner, K., Newman, K.[2020]
References
In vitro delivery of aerosolized treprostinil via modern mechanical ventilation. [2017]
Inhaled Treprostinil Drug Delivery During Mechanical Ventilation and Spontaneous Breathing Using Two Different Nebulizers. [2018]
Long-acting anticholinergic use in chronic obstructive pulmonary disease: efficacy and safety. [2015]
Effects of inhaled tiotropium plus transdermal tulobuterol versus tiotropium alone on impulse oscillation system (IOS)-assessed measures of peripheral airway resistance and reactance, lung function and quality of life in patients with COPD: a randomized crossover study. [2015]
Efficacy and safety of a first-in-class inhaled PDE3/4 inhibitor (ensifentrine) vs salbutamol in asthma. [2020]
Pharmacokinetics and tolerability of LIQ861, a novel dry-powder formulation of treprostinil. [2020]
Comparative bioavailability of inhaled treprostinil administered as LIQ861 and Tyvaso® in healthy subjects. [2021]
Rapid transition from inhaled iloprost to inhaled treprostinil in patients with pulmonary arterial hypertension. [2022]
Acute effects of the combination of sildenafil and inhaled treprostinil on haemodynamics and gas exchange in pulmonary hypertension. [2022]
The potential for inhaled treprostinil in the treatment of pulmonary arterial hypertension. [2017]
Other People Viewed
By Subject
By Trial
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.