DEVELOPMENT OF INNOVATIVE TARGETED LIPOSOMAL FORMULATIONS FOR THE TREATMENT OF INFLAMMATORY DRIVEN PULMONARY FIBROSIS

NCT07571291 | Active Not Recruiting

• 1 other identifier: P_461_2022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to develop an innovative nano-platform for the treatment of lung fibrogenic disorders (LFD). The approach involves local delivery by inhalation of drug-loaded liposomes, coated with hyaluronic acid (HA) to directly target CD44+ pathogenic cells. We aim to expand and develop the formulation "XHALIP¿ (patent pending) by the following steps: 1) Characterization of safety and bioavailability in healthy and lung fibrogenic disorders (LFD) mice; 2) Evaluation of the pharmacokinetics and uptake by human LFD fibroblasts and macrophages and on healthy/LFD mice; 3) testing of antifibrotic/-inflammatory activities of the most promising XHALIP on mouse LFD models and translational studies on lung cells/tissues from LFD patients AIM 1: XHALIP characterization and bio-nano interaction AIM 2: Organ and cell lung Targeting AIM 3: Efficacy assessment in lung fibrosis models

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• liposome characterization and bio-nano interaction

  12 months

Interventions

liposomes as drug delivery system DEVICE

TEst in vitro ability of specific liposomes to deliver drugs to fibroblasts and macrophages from pulmonary fibrosis patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Rheumatology and Pneumology unit

You may qualify if:

• diagnosis of pulmonary fibrotic conditions (idiopathic, Connective Tissue Disease Associated)

You may not qualify if:

• Unwilling to provide informed consent

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Rheumatology unit IRCCS Policlinico San Matteo Pavia

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)