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Study of Inhaled Imatinib Nanoformulation XHALIP for Treating Pulmonary Arterial Hypertension and Fibrosing Lung Diseases in Adults Evaluating Drug Absorption and Effects on Lung Cells
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-04-08
16
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating XHALIP, a new inhalable form of Imatinib, in patients with pulmonary arterial hypertension PAH and post-inflammatory fibrosing lung diseases LFD. The study aims to show that XHALIP can improve outcomes by reducing lung fibrosis and blood vessel changes. This proof-of-concept research focuses on how well the drug is absorbed by lung cells and its effects on cell growth and tissue scarring. The study involves laboratory tests using cells from patients with PAH and LFD, including those who are candidates for or have received lung transplants. Researchers will examine drug absorption and distribution using lung tissue models and assess biological effects such as inhibiting harmful cell changes and proliferation. These preclinical studies will help develop XHALIP as an inhalable treatment for rare lung diseases. Participants will provide biological samples like lung washings and explanted lung tissues for analysis. Advanced techniques such as confocal microscopy, flow cytometry, RT-PCR, and Western Blot will be used to study drug absorption and activity. The study will measure outcomes related to the synthesis and characterization of XHALIP over two years, with the goal of supporting future clinical trials. Participation involves laboratory-based evaluations without direct treatment administration.
CONDITIONS
Brief Title
PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.
Research Team
S
Stefano Ghio, MD
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