NCT06917196 PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.
| NCT ID | NCT06917196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 16 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2025-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 16 participants in total. It began in 2023-12-04 with a primary completion date of 2025-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The PROMPTLY study is a proof-of-concept research project evaluating the efficacy of XHALIP, an innovative inhalable formulation of Imatinib, in treating pulmonary arterial hypertension (PAH) and post-inflammatory fibrosing lung diseases (LFD). Main Objective To demonstrate the ability of XHALIP to improve the prognosis of PAH and LFD by reducing pulmonary fibrosis and vascular remodeling. Key Research Questions Is XHALIP effectively absorbed by pathological lung cells? Does it have a beneficial biological effect on cell proliferation and extracellular matrix deposition? Study Plan Preclinical phase: In vitro tests on cells obtained from patients with PAH and LFD. Absorption and distribution analysis: In vitro lung tissue models to assess drug penetration and effectiveness. Biological activity assessment: Evaluating XHALIP's ability to inhibit epithelial-mesenchymal transition and cell proliferation. Participants Patients aged ≥ 18 years diagnosed with PAH or LFD, either candidates for or recipients of lung transplantation. Biological samples (bronchoalveolar lavage and explanted lung tissues). Methodology Confocal microscopy and flow cytometry to analyze absorption. RT-PCR and Western Blot to assess biological efficacy. Alveolo-capillary models to test drug release and distribution. The study aims to translate preclinical findings into a potential future clinical trial for the development of XHALIP as a novel inhalation-based therapeutic strategy for rare lung diseases.
Eligibility Criteria
Inclusion Criteria: * Patients aged ≥ 18 years diagnosed with fibrosing lung disease, obliterative bronchiolitis, or PAH, who are candidates for or have undergone lung transplantation. * Obtaining informed consent for all patients enrolled prospectively and all those enrolled retrospectively at their first clinical occurrence at our center. Exclusion Criteria: * Suspected or confirmed diagnosis of pulmonary neoplastic disease.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06917196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Arterial Hypertension (PAH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06917196 currently recruiting?
Yes, NCT06917196 is actively recruiting participants. Contact the research team at s.ghio@smatteo.pv.it for enrollment information.
Where is the NCT06917196 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06917196 clinical trial?
NCT06917196 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 16 participants.