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Active, not recruitingNCT07571291Updated May 6, 2026

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

An observational study in Pulmonary Fibrosis, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Active, not recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
All
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Study 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

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Conditions studied

  • Pulmonary Fibrosis

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03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's planned enrollment of 30 is below the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

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Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients of the Rheumatology and Pneumology unit

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unwilling to provide informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Deviceliposomes as drug delivery system

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

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What researchers measure

Primary outcomes

  1. liposome characterization and bio-nano interaction

    Time frame: 12 months

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Study locations

1 site
  • Rheumatology unit IRCCS Policlinico San Matteo Pavia
    Pavia, 27100, Italy
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References and documents

Individual participant data

Plan to share: No — A patent is pending for the liposomes in study

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07571291
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible party
Veronica Codullo (MD PhD, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
May 6, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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