L606 for Pulmonary Hypertension
(Re-Spire Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests L606, a potential new treatment for individuals with high blood pressure in the lungs due to interstitial lung disease (PH-ILD). The primary goal is to determine if L606 is safe and improves performance in a six-minute walk test. The trial will also assess the time it takes for the condition to worsen while on L606. Participants will be randomly assigned to receive either L606 or a placebo. Individuals with PH-ILD, diagnosed through specific tests and able to walk at least 150 meters in six minutes, may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that L606 is likely to be safe for humans?
Research has shown that L606 is generally well-tolerated by people with high blood pressure in the lungs. Previous studies reported no serious side effects linked to the treatment, suggesting that L606 is safe for patients. These studies also examined repeated doses to ensure the treatment remains safe over time. While side effects can occur, the evidence so far indicates that L606 is a manageable treatment option for this condition.12345
Why do researchers think this study treatment might be promising for pulmonary hypertension?
L606 is unique because it combines with a nebulizer for targeted delivery, potentially offering a more efficient treatment for pulmonary hypertension compared to oral or injectable therapies. Unlike standard treatments like endothelin receptor antagonists or phosphodiesterase-5 inhibitors, L606 may introduce a new mechanism of action, which could better manage symptoms or slow disease progression. Researchers are excited about L606 because it might provide improved efficacy and convenience for patients struggling with this challenging condition.
What evidence suggests that L606 might be an effective treatment for pulmonary hypertension?
Research has shown that L606 might help treat high blood pressure in the lungs caused by lung disease. In earlier studies, people who used L606 could walk farther in six minutes, suggesting it might improve daily activities. In this trial, participants will receive either L606 or a placebo, both with a nebulizer, to test safety and effectiveness. Studies are examining how long it takes for the condition to worsen while using L606. Early results suggest that L606 may slow the progression of the disease.16789
Are You a Good Fit for This Trial?
This trial is for adults aged 18–80 who have high blood pressure in the lungs due to interstitial lung disease (PH-ILD). Participants must be able to walk at least 150 meters in six minutes and meet certain heart and lung function criteria confirmed by scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either L606 or placebo to evaluate safety and efficacy, including the six-minute walk test
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may opt into continuation of treatment with L606 long-term
What Are the Treatments Tested in This Trial?
Interventions
- L606
Trial Overview
The study compares a new drug called L606 with a placebo (inactive treatment) in people with PH-ILD. Participants are randomly assigned to either group, and doctors will track how far they can walk over time and monitor their health closely.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Liquidia Technologies, Inc.
Lead Sponsor
Citations
Long-term outcomes in pulmonary arterial hypertension ... - PMC
The Patient Registry for the Characterization of Primary Pulmonary Hypertension reported a median survival of almost six years for patients in FC I or FC II ...
NCT04691154 | A Phase 3 Study to Evaluate the Safety ...
Active, not recruiting. A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD. ClinicalTrials.gov ID NCT04691154.
3.
liquidia.com
liquidia.com/news-releases/news-release-details/liquidia-provides-update-clinical-pipeline-targeting-pah-and-phLiquidia Provides Update on Clinical Pipeline Targeting ...
L606 is currently being evaluated in an open-label study in the United States for treatment of PAH and PH-ILD with a planned pivotal study for ...
Pulmonary Hypertension Clinical Trials
The purpose of this study is to assess the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary arterial hypertension.
Efficacy of Riociguat on pulmonary hypertension
Abstract: Aims: Riociguat might be a promising approach to treat pulmonary hypertension. However, the results have been controversial.
6.
liquidia.com
liquidia.com/news-releases/news-release-details/liquidia-present-clinical-data-across-its-portfolio-pulmonaryLiquidia to Present Clinical Data Across Its Portfolio at the ...
The primary objective of this study is to evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 & 3 Pulmonary Hypertension ...
7.
ctv.veeva.com
ctv.veeva.com/study/a-phase-3-study-to-evaluate-the-safety-and-efficacy-l606-in-participants-with-ph-ildA Phase 3 Study to Evaluate the Safety and Efficacy L606 in ...
The purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary ...
A Phase 3 Study to Evaluate the Safety and Tolerability of ...
Overview. This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH ...
L606 Inhalation Suspension for Pulmonary Arterial ...
The principal aim of this study is to obtain safety and tolerability data when L606 is administered as an oral inhalation as single doses to healthy. Page 15 ..
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