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Prostacyclin Analog
L606 Inhalation Suspension for Pulmonary Arterial Hypertension
Phase 3
Waitlist Available
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
No Placebo-Only Group
Pivotal Trial
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 belowSelect...
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:Select...
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.
Select...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: L606Experimental Treatment1 Intervention
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.
Medications for the treatment of pulmonary arterial hypertension: a systematic review and network meta-analysis.
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Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,287 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
55 Patients Enrolled for Pulmonary Arterial Hypertension
Liquidia Technologies, Inc.Lead Sponsor
6 Previous Clinical Trials
469 Total Patients Enrolled
3 Trials studying Pulmonary Arterial Hypertension
228 Patients Enrolled for Pulmonary Arterial Hypertension
Pharmosa Biopharm Inc.Lead Sponsor
3 Previous Clinical Trials
172 Total Patients Enrolled
3 Trials studying Pulmonary Arterial Hypertension
172 Patients Enrolled for Pulmonary Arterial Hypertension
PPDIndustry Sponsor
161 Previous Clinical Trials
36,363 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
55 Patients Enrolled for Pulmonary Arterial Hypertension
Jeremy P Feldman, MDPrincipal InvestigatorArizona Pulmonary Specialists
Elizabeth Gay, MDPrincipal InvestigatorBrigham and Women's Hospital
Michael G Risbano, MDPrincipal InvestigatorUPMC Montefiore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have some level of difficulty with physical activity due to heart problems.I have been diagnosed with a specific type of lung hypertension for at least a year.I am between 18 and 80 years old and use effective birth control if sexually active.Your heart's electrical activity, as shown on a test called an electrocardiogram (ECG), is abnormal.I can walk 150 meters or more without stopping.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.I have a condition like severe arthritis or a recent joint replacement that limits my ability to walk.My heart's pumping ability is reduced (LVEF ≤45%) based on a recent test.I have a history of sleep apnea or heart disease on the left side.Your blood pressure is too low (less than 90) or too high (more than 160) when the study starts.If you have pulmonary arterial hypertension (PAH), your lung function must be above a certain level. If you have pulmonary hypertension associated with interstitial lung disease (PH-ILD), your lung function must also meet specific requirements.
Research Study Groups:
This trial has the following groups:- Group 1: L606
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.