The Re-Spire Clinical Study
A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of L606 (Treprostinil Liposome Inhalation Suspension) in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD; WHO Group 3).
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About The Study
The goal of the Re-Spire Study is to learn if the investigational study drug works and is safe in the long-term for people living with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) (WHO Group 3).
Researchers want to know:
- Is the investigational study drug safe?
- Does it work well?
- Does it improve the ability to exercise?
What is L606?
The investigational study drug L606 is an inhaled formulation of treprostinil that is currently being evaluated in the Respire clinical research study and is not approved by the U.S. Food and Drug Administration (FDA). Treprostinil, the active molecule in L606, is already approved by the FDA and other regulatory agencies in different formulations for the treatment of pulmonary hypertension. L606 uses a liposomal delivery system—a tiny lipid or fat particle—which is being studied to evaluate the safety and efficacy of administering an extended release formulation of treprostinil twice daily.
Study Listing
For more technical details, you can view the official study listing on ClinicalTrials.gov.
Who Can Join
This study will have about 350 participants.
Key Participation Requirements:
Diagnosis: Participants with Pulmonary Hypertension (PH) and lung disease who are in WHO Group 3.
Eligibility: Tests and exams during the first 30 days will help researchers determine if you are eligible for the study.
Daily Commitment: The study includes daily nebulizer treatments, device cleaning, and Dosing Diary entries.
What To Expect
The Re-Spire Study is a single study with two phases that you may potentially join:
Blinded Treatment Phase (Approximately 28 weeks)
- At Day 1, you have an equally random chance of getting assigned to either the investigational study drug (L606) or a placebo.
- Both you and the study team will not know whether you are receiving the investigational study drug or a placebo, which is called "double-blinded".
- Your dose of investigational study drug will increase until you reach the maximum dose you can safely tolerate.
Open-Label Extension Phase (Approximately 6 years)
- This is called "open-label" because there is no placebo and everyone will take the investigational study drug, L606.
- This phase will allow study participants to continue to have access to L606 and will allow researchers to continue to study its long-term safety.
Frequently Asked Questions (FAQs)
Locations
The Re-Spire Study will be conducted in more than 100 locations around the world across the following regions:
North America
- Canada
- Mexico
- United States
South America
- Argentina
- Brazil
- Colombia
Europe
- Austria
- Belgium
- Czech Republic
- France
- Germany
- Italy
- Latvia
- Poland
- Portugal
- United Kingdom
Middle East
- Turkey
Asia-Pacific
- Australia
- China
- Singapore
- Taiwan
Share This Study
If you know someone who might be interested in learning more about the Re-Spire Study, you can share this information with a friend, family member, or your physician.
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