Possible New Inhaled Treatment Option for PH with ILD
Trial Objectives
Pulmonary hypertension (PH), or high blood pressure in the lungs, can often develop in those who have interstitial lung disease (ILD). Treatments for this combination of diseases, called PH-ILD, to try and improve quality of life for people with both conditions are currently being evaluated. In the national ASCENT trial, researchers are testing an inhaled treatment called LIQ861 to see if it is safe, effective and can help improve exercise capacity in people with PH-ILD.
Volunteers will be asked to complete exercise testing in the screening visits to determine if they qualify for this clinical trial. Qualified participants will receive treatment with an inhaled powder medication called LIQ861. Researchers will evaluate if the medication has any side effects, as well as its impacts on exercise tolerance.
At clinic visits, volunteers will receive physical examinations and will be asked to complete exercise testing. They also will be asked to complete questionnaires about their symptoms and may receive imaging tests.
Who Can Participate
Participants must have a confirmed diagnosis of WHO Group 3 Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD). They also must be able to walk a distance of 125 meters or more on two six-minute walk tests during the screening and baseline assessments. If taking chronic medication, participants must be on a stable dose during the trial.
Age: 18-75 Gender: Any
Estimated Time Commitment
Six visits over approximately 52 weeks, with two initial visits for enrollment and then visits at weeks 8, 16, 24 and 52.
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
Liquidia Technologies, Inc.
Principal Investigators
Marjorie Patricia George, MD
Co-Investigators
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Darlene Kim, MD, FACC
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Tim Lahm, MD, ATSF
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Adriel J. Malavé, MD