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28 Participants Needed

L606 Inhalation Suspension for Pulmonary Arterial Hypertension

Recruiting at 4 trial locations

Overseen ByMarisa C. Law

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Liquidia Technologies, Inc.

Disqualifiers: Sleep apnea, Left-sided heart disease, others

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

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What makes the drug L606 unique for treating pulmonary arterial hypertension?

L606 is an inhalation suspension, which means it is administered directly into the lungs, potentially offering a more targeted approach compared to oral or intravenous treatments. This method could provide more direct effects on the pulmonary arteries, possibly reducing systemic side effects.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

This trial tests a new medication called L606 in patients with specific types of lung disease. It aims to see if L606 is safe, helps patients breathe better, and improves their quality of life compared to an existing treatment called Tyvaso. LIQ861 is a novel dry-powder formulation of treprostinil, similar to the inhaled, nebulized treprostinil (Tyvaso®).

Research Team

Jeremy P Feldman, MD

Principal Investigator

Arizona Pulmonary Specialists

Elizabeth Gay, MD

Principal Investigator

Brigham and Women's Hospital

Michael G Risbano, MD

Principal Investigator

UPMC Montefiore

Eligibility Criteria

This trial is for adults aged 18-80 with Pulmonary Arterial Hypertension (PAH) or PH due to Lung Disease (PH-ILD), who can walk at least 150 meters and have a certain level of heart and lung function. They must not have severe heart disease, uncontrolled blood pressure, recent serious illness, liver dysfunction, or kidney failure requiring dialysis.

Inclusion Criteria

I have some level of difficulty with physical activity due to heart problems.

Able to understand and complete study requirements and provide written informed consent

I have been diagnosed with a specific type of lung hypertension for at least a year.

See 2 more

Exclusion Criteria

Your heart's electrical activity, as shown on a test called an electrocardiogram (ECG), is abnormal.

My liver enzymes are not more than three times the normal limit and I don't have severe liver disease.

My kidney function is very low or I am on dialysis.

See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Study Period (MSP)

Participants receive L606 to evaluate short-term safety and tolerability

2 weeks for Cohort A, 12 weeks for Cohort B

Open-label Extension Period (OEP)

Participants continue L606 dosing to evaluate long-term safety and tolerability

46 weeks for Cohort A, 36 weeks for Cohort B

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

L606

Trial Overview The study tests the safety and tolerability of L606 inhalation suspension in PAH or PH-ILD patients. It compares its effects on exercise ability, quality of life, and treatment satisfaction against Tyvaso over short-term and long-term use.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: L606Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Liquidia Technologies, Inc.

Lead Sponsor

Trials

Recruited

500+

Pharmosa Biopharm Inc.

Lead Sponsor

Trials

Recruited

200+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

PPD Development, LP

Industry Sponsor

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Findings from Research

Recent clinical trials have shifted the treatment approach for pulmonary arterial hypertension (PAH) from a clinical-based strategy to an evidence-based therapy, allowing for a more systematic treatment algorithm based on the efficacy and side-effect profiles of various approved drugs.

The proposed treatment algorithm is specifically designed for patients in NYHA functional class III or IV, recommending oral anticoagulation for all, and suggesting specific therapies like endothelin receptor antagonists or prostanoids for nonresponders to acute vasoreactivity testing, with continuous intravenous epoprostenol as a rescue option for the most severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of clinical trials and evidence-based treatment algorithm in pulmonary arterial hypertension.Galiè, N., Seeger, W., Naeije, R., et al.[2021]

Early recognition and referral of patients with pulmonary arterial hypertension (PAH) to specialized centers is crucial for improving outcomes, as novel treatments and rehabilitation programs can enhance exercise capacity and quality of life.

Current medical treatments, including prostanoids and endothelin antagonists, not only promote pulmonary vasodilation but may also address the underlying vascular abnormalities in PAH, with emerging evidence suggesting that combination therapy may be more effective than single-agent treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment approaches to pulmonary arterial hypertension.Provencher, S., Granton, JT.[2022]