Evaluating inhalable Imatinib for treating pulmonary hypertension and lung fibrosis
PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.
Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06917196
This study is testing a new inhalable medication called XHALIP to see if it can help people with pulmonary hypertension and lung fibrosis feel better by improving their lung health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia (other) |
| Drugs / interventions | Imatinib |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06917196 on ClinicalTrials.gov |
What this trial studies
This proof-of-concept study investigates the efficacy of XHALIP, an innovative inhalable formulation of Imatinib, in patients with pulmonary arterial hypertension (PAH) and post-inflammatory fibrosing lung diseases (LFD). The research focuses on assessing the absorption of XHALIP by pathological lung cells and its biological effects on cell proliferation and extracellular matrix deposition. The study employs in vitro tests using lung tissue models to analyze drug penetration and effectiveness, aiming to demonstrate improvements in prognosis by reducing pulmonary fibrosis and vascular remodeling.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with PAH or fibrosing lung disease who are candidates for or have undergone lung transplantation.
Not a fit: Patients with suspected or confirmed pulmonary neoplastic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from pulmonary hypertension and lung fibrosis.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in targeting lung diseases with inhalable formulations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pavia, Italy (RECRUITING)
Study contacts
- Study coordinator: Stefano Ghio, MD
- Email: s.ghio@smatteo.pv.it
- Phone: +39 0382503460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Arterial Hypertension, Lung Fibrosis Interstitial, PAH, LFD, Pulmonary arterial hypertension, lung fibrosis desease, XHALIP, imatinib