Pulmonary hypertension associated with interstitial lung disease (PH-ILD) is a lung condition characterized by increased blood pressure in the lungs, which means the heart must work harder to pump blood to the lungs.
There is currently only 1 medication approved in some countries to treat PH-ILD. Other care for PH-ILD includes supportive care and medications that can help manage the underlying condition.
The PHrontier Study is testing the safety and effectiveness of an investigational drug called mosliciguat in treating adults living with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Your participation in the PHrontier Study will help us learn about the study drug, mosliciguat, and could help others with PH-ILD in the future.
If you qualify and decide to take part in the study, you may receive:
You may be able to join the study if you:
Other requirements need to be met to join the PHrontier Study. Please contact us for details.
The PHrontier Study will last about 14 ½ months. Participation involves 12 in-clinic visits and 9 virtual visits at home, and includes:
After screening to determine eligibility, participants will be randomly assigned (like drawing straws) to receive either mosliciguat or placebo during the 24-week treatment period. The placebo looks like mosliciguat but contains no active ingredients. Participants will have a 1-in-2 (50%) chance of receiving mosliciguat during this period.
After the treatment period, participants will take part in an extension period of the study, during which everyone will receive mosliciguat for up to 28 weeks. No placebo will be given during the extension period.
Mosliciguat (or placebo) is given once daily using a dry powder inhaler.
A clinical trial is carefully supervised research that is done to learn if and how well an investigational drug works for the condition under study and the drug's safety. Most medications, treatments, medical devices, and tools used in the medical field today started in a clinical trial. Regulatory agencies must review the results from clinical trials before approving a medication, treatment, or medical device. Participants in clinical trials must meet specific criteria to participate and can withdraw from a study at any time.
Strict rules must be followed during clinical trials to help protect the rights, safety, and privacy of the people taking part. The rules also make sure the studies are done ethically and meet approved medical standards.
What is the purpose of the PHrontier Study?
The PHrontier Study is testing the safety and effectiveness of an investigational drug called mosliciguat in treating adults living with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
What will the study involve?
The PHrontier Study will last about 14 ½ months and includes:
After screening to determine eligibility, participants will be randomly assigned (like drawing straws) to receive either mosliciguat or placebo during the 24-week treatment period. The placebo looks like mosliciguat but contains no active ingredients. Participants will have a 1-in-2 (50%) chance of receiving mosliciguat during this period.
After the treatment period, participants will take part in an extension period of the study, during which everyone will receive mosliciguat for up to 28 weeks. No placebo will be given during the extension period.
Mosliciguat (or placebo) is given once daily using a dry powder inhaler.
Participation involves 12 in-clinic visits and 9 virtual visits at home.
Do I have to take part in the PHrontier Study?
Joining the PHrontier Study is voluntary, meaning it is completely up to you. Deciding not to take part will not affect your usual medical care now or in the future. If you take part, you can decide to leave the study at any time and for any reason.
What happens in a clinical study?
During a clinical study, you'll receive the investigational drug that is being studied, or placebo.
In a clinical study, participants undergo a series of tests and procedures to gather information about a medical intervention, such as a new drug or treatment. The study begins with a screening visit where potential participants are evaluated to see if they meet the criteria for the study. Once eligibility is confirmed, participants receive the investigational drug that is being studied, or placebo at a predefined frequency. Throughout the study, the participants' health and response to the investigational drug is closely monitored through regular visits, tests, and procedures. This may include physical exams, vital signs, blood and urine samples, medical imaging, and other assessments according to the study protocol. All participants are always closely monitored by the study staff and the medical team to ensure their safety.
Placebo: A placebo looks like the investigational drug being tested, but it doesn't have any active ingredients. It is given the same way as the investigational drug. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Will I be reimbursed for study-related travel and expenses?
The study sponsor, Pulmovant, Inc., will reimburse all study participants for certain study-related expenses, such as travel and meals. For more information, please speak with a member of the study team during your study visits.
Why participate in clinical research?
There are many reasons to participate in clinical research. By joining a clinical trial, you have the opportunity to access new treatments or therapies that are not yet available to the public. This can be especially important for people with conditions that have limited treatment options. Additionally, your participation can contribute to the advancement of medical knowledge and helps researchers better understand diseases and how to treat them. Most medications, treatments, medical devices, and tools used in the medical field today started in a clinical trial. While there is no guarantee that you will receive any benefit from participating, other people who live with the disease or condition may benefit from what is learned in the clinical trial. The clinical trial is monitored while it is ongoing, including by the sponsor and appropriate regulatory agencies/health authorities.
How am I protected if I decide to participate?
Every clinical trial must be reviewed by a regulatory authority, which is a government agency set up to enforce safety standards and protect study participants. Every clinical trial must also be reviewed and approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC), organizations that ensure the study is ethical and that the risks to study participants do not outweigh the benefits.
Before you take part, you will go through an informed consent process, where the study team will explain the purpose, tests and procedures, potential risks and potential benefits of the study, allowing you to make an informed decision about your participation. Additionally, your privacy and confidentiality are strictly protected; any information collected about you will be handled with care and only shared with authorized individuals. Throughout the study, you will have the right to ask questions, receive updates, and withdraw from the study at any time without penalty or loss of benefits to which you are otherwise entitled. These safeguards are designed to prioritize your safety and respect your autonomy as a study participant.
Who is responsible for conducting this clinical study?
The study is conducted and funded by the sponsor, Pulmovant, Inc. The study is under the direction of the Principal Investigator and the research staff at the respective clinical site where participants are enrolled.
Please select the study center that is most convenient for you.
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