PROOF OF CONCEPT STUDY ON THE EFFICACY OF INHALATORY TARGETED IMATINIB NANOFORMULATIONS IN PULMONARY HYPERTENSION AND POST-INFLAMMATORY FIBROSIS.

NCT06917196 | Recruiting

• 1 other identifier: PROMPTLY
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension (PAH); Lung Fibrosis Interstitial

Keywords

PAH; LFD; Pulmonary arterial hypertension; lung fibrosis desease; XHALIP; imatinib

Outcome Measures

Primary Outcomes (3)

• Complete synthesis and characterization of XHALIP for in vitro studies.

  Preparation and stabilization of the dry powder formulation of XHALIP.

  two years from the enrollment

• Complete synthesis and characterization of XHALIP for in vitro studies.

  Evaluation of XHALIP uptake by various cell types obtained ex vivo from patients with LFD and PAH, as well as transplant recipients (endothelial, epithelial, MC, PASMC, inflammatory effector cells), cultured in vitro and in co-culture systems.

  two years from the enrollment

• Complete synthesis and characterization of XHALIP for in vitro studies.

  Evaluation of CD44 expression by various cell types obtained ex vivo from patients with LFD and PAH, as well as transplant recipients (endothelial, epithelial, MC, PASMC, inflammatory effector cells), cultured in vitro and in co-culture systems.

  two years from the enrollment

Secondary Outcomes (2)

• Exploration of XHALIP Distribution

  two years from the enrollment

• Exploration of XHALIP Distribution

  two years from the enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects are enrolled at the Fondazione IRCCS Policlinico San Matteo hospital in Pavia, at the SC of Pulmonology of the Foundation.

You may qualify if:

• 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.

You may not qualify if:

• Suspected or confirmed diagnosis of pulmonary neoplastic disease.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefano Ghio, MD

CONTACT

+39 0382503460; s.ghio@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 8, 2025
• Study Start: December 4, 2023
• Primary Completion: December 4, 2025
• Study Completion (Estimated): June 4, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

IT (1)