Actively Recruiting

Age: 18Years +
All Genders
ID06917196

Proof of Concept Study on the Efficacy of Inhaled Targeted Imatinib Nanoformulations in Pulmonary Hypertension and Post-Inflammatory Fibrosis

Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-04-08

16

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating XHALIP, a new inhalable form of Imatinib, in patients with pulmonary arterial hypertension (PAH) and post-inflammatory fibrosing lung diseases (LFD). The study aims to show that XHALIP can improve outcomes by reducing lung fibrosis and blood vessel changes. This proof-of-concept research focuses on how well the drug is absorbed by lung cells and its effects on cell growth and tissue scarring. The study involves laboratory tests using cells from patients with PAH and LFD, including those who are candidates for or have received lung transplants. Researchers will examine drug absorption and distribution using lung tissue models and assess biological effects such as inhibiting harmful cell changes and proliferation. These preclinical studies will help develop XHALIP as an inhalable treatment for rare lung diseases. Participants will provide biological samples like lung washings and explanted lung tissues for analysis. Advanced techniques such as confocal microscopy, flow cytometry, RT-PCR, and Western Blot will be used to study drug absorption and activity. The study will measure outcomes related to the synthesis and characterization of XHALIP over two years, with the goal of supporting future clinical trials. Participation involves laboratory-based evaluations without direct treatment administration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older diagnosed with fibrosing lung disease, obliterative bronchiolitis, or pulmonary arterial hypertension
  • Candidates for or recipients of lung transplantation
  • Able to provide informed consent for participation
Not Eligible

You will not qualify if you...

  • Suspected or confirmed diagnosis of lung cancer

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 2 years from enrollment

Participants are observed over time to gather data on the progression and characteristics of pulmonary hypertension and post-inflammatory fibrosis.

Visits scheduled periodically over 2 years

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

S

Stefano Ghio, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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