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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will study the safety and tolerability of L606 in patients with pulmonary arterial hypertension who are switching from a stable Tyvaso dose.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs (long-term)
Secondary outcome measures
Pharmacokinetics assessed by steady-state PK parameters of treprostinil from Tyvaso and L606
Safety/Tolerability assessed by incidence of treatment-emergent AEs/SAEs
Other outcome measures
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: L606Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
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
2 Previous Clinical Trials
116 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
116 Patients Enrolled for Pulmonary Arterial Hypertension
PPDIndustry Sponsor
159 Previous Clinical Trials
36,855 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
55 Patients Enrolled for Pulmonary Arterial Hypertension
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are helping with this research?
"That is accurate. The clinicaltrials.gov website says that the trial, which was originally posted on 8/1/2021, has not yet reached its full complement of 60 participants at 1 site."
Answered by AI
Is L606 inhalation suspension associated with short-term or long-term risks?
"L606 inhalation suspension safety is estimated to be a 3. This comes from it being in Phase 3 trials which have data supporting both its efficacy and safety from multiple rounds of testing."
Answered by AI
Are patients who are 55 years or older eligible for this program?
"Individuals that want to participate in this trial must be aged 18-75. In contrast, there are 56 other ongoing medical studies for patients below the age of majority and 695 research trials for seniors."
Answered by AI
Are there any current openings for this kind of research?
"Yes, this clinical trial is open and recruiting patients. The listing on clinicaltrials.gov shows that the study was first posted on 8/1/2021 and last updated 1/26/2022."
Answered by AI
How can I become a part of this experiment?
"This ongoing study is looking for 60 volunteers who have pulmonary arterial hypertension and are between 18-75 years old. In order to be eligible, patients must also meet the following requirements: Be male or female, ≥18 and ≤75 years of age at the time of informed consent., Be in New york Heart Association functional class II, III, or IV at the screening visit., Have a documented stable dosage, have an FEV1 >65% of predicted and FEV1/forced vital capacity (FVC) ratio >65%, able to complete a screening 6MWD of ≥150 meters,, Key, understand and be willing to"
Answered by AI
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