What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include prostacyclin analogues (e.g., treprostinil), endothelin receptor antagonists (ERAs) (e.g., bosentan, ambrisentan), and phosphodiesterase type 5 inhibitors (PDE-5Is) (e.g., sildenafil). Known side effects of these treatments can include headache, nausea, diarrhea, flushing, jaw pain, hepatotoxicity, peripheral edema, and hypotension. Specific to treprostinil, side effects may also include cough, dizziness, and fatigue. These side effects are important considerations for patients and healthcare providers when choosing an appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH), including prostacyclin derivatives like treprostinil and iloprost, which improve exercise capacity and hemodynamics. Additionally, phosphodiesterase-5 inhibitors (PDE5Is) such as sildenafil and tadalafil, and endothelin receptor antagonists (ERAs) like bosentan and ambrisentan, have been approved for PAH. These treatments aim to improve symptoms, exercise ability, and quality of life in patients with PAH.

What other types of research exist?

Promising novel alternatives to L606 for PAH patients include: <ol> <li>Oral Bosentan: Effective and safe for long-term treatment across various types of PAH.</li> <li>Inhaled Iloprost: Demonstrated efficacy in improving exercise capacity and hemodynamics.</li> <li>New Formulation of Flolan (Epoprostenol): More thermostable and effective at higher doses.</li> <li>Oral Treprostinil: Shown to improve time to clinical worsening when added to other oral agents.</li> <li>PDE5 Inhibitors (e.g., Sildenafil, Tadalafil): Improve exercise capacity and hemodynamics, with significant benefits in functional class and survival.</li> </ol>

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Prostacyclin Analog

L606 Inhalation Suspension for Pulmonary Arterial Hypertension

Phase 3

Recruiting

Led By Jeremy P Feldman, MD

Research Sponsored by Liquidia Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA functional class II, III, or IV at the screening visit

Diagnosed with PAH belonging to at least 1 of the following subgroups of Group 1 pulmonary hypertension (PH) per European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH at least 1 year prior to screening or PH-ILD Group 3 European Society of Cardiology/European Respiratory Society Guidelines for the diagnosis and treatment of PH. Subjects with Group 3 PH that is not related to underlying ILD are not eligible

Must not have

Alanine aminotransferase or aspartate aminotransferase levels >3 × upper limit of normal reference range, clinically significant liver disease/dysfunction, or known Child-Pugh Class C hepatic disease

Estimated glomerular filtration rate <30 mL/min/1.73 m2 or requires dialysis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

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®).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones for inhalation treatments like L606 may include coughing, throat irritation, headache, nausea, dizziness or worsening of existing respiratory symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can walk 150 meters or more without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a condition like severe arthritis or a recent joint replacement that limits my ability to walk.

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My heart's pumping ability is reduced (LVEF ≤45%) based on a recent test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)

Secondary study objectives

Pharmacokinetics assessed by steady-state PK parameters of treprostinil from Tyvaso and L606

Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs

Other study objectives

Cohort A and Cohort B: Quality of Life assessed by PAH-specific Quality of Life questionnaire Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).

Efficacy of L606 assessed by 6MWD at steady-state morning trough and peak concentrations of treprostinil

Efficacy of L606 assessed by 6MWD at steady-state morning trough and peak concentrations of treprostinil (long-term)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: L606Experimental Treatment1 Intervention

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include prostacyclin analogs, phosphodiesterase-5 inhibitors (PDE5Is), and endothelin receptor antagonists (ERAs). Prostacyclin analogs, such as epoprostenol and treprostinil, work by dilating blood vessels and inhibiting platelet aggregation, which helps reduce pulmonary vascular resistance. PDE5Is, like sildenafil and tadalafil, enhance the effect of nitric oxide by inhibiting the enzyme PDE5, leading to vasodilation and improved blood flow in the lungs. ERAs, such as bosentan, block the action of endothelin-1, a potent vasoconstrictor, thereby reducing blood vessel constriction and lowering blood pressure in the pulmonary arteries. These treatments are crucial for PAH patients as they help improve exercise capacity, quality of life, and overall prognosis by targeting the underlying mechanisms of the disease.

Medications for the treatment of pulmonary arterial hypertension: a systematic review and network meta-analysis.