New Diagnostic Approaches in the Management of Inflammatory Lung Diseases

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi ETS

About this trial

Inflammatory lung diseases, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), are major causes of morbidity and mortality worldwide. Their development and progression are influenced by environmental exposures, such as cigarette smoking and air pollution, as well as genetic susceptibility. Despite advances in disease management, early diagnosis, accurate differential diagnosis, personalized treatment, and continuous monitoring remain significant clinical challenges.

This project aims to improve the management of inflammatory lung diseases through the development and validation of innovative diagnostic, monitoring, and therapeutic approaches. The study will identify and validate multi-omics biomarkers for the differential diagnosis and prognosis of COPD, IPF, and related respiratory diseases, using machine learning techniques to develop diagnostic and prognostic biochips. Environmental determinants, including indoor and outdoor exposome factors, will be assessed to better understand their contribution to pulmonary inflammation and disease progression. The project will also develop nanotechnology-based therapeutic formulations combined with precision inhalation devices and integrate a telemedicine platform for real-time monitoring of clinical and environmental data, enabling the early detection of exacerbations and supporting personalized disease management.

The expected outcomes include improved diagnostic accuracy, enhanced risk stratification, personalized therapeutic strategies, reduced disease exacerbations, and improved quality of life for patients with inflammatory lung diseases.

Eligibility criteria

Qualifiers

Adults aged 18 years or older.

Diagnosis of chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), or combined pulmonary fibrosis and emphysema (CPFE), established according to current international diagnostic guidelines.

Ability and willingness to provide written informed consent.

Willingness to provide blood and saliva samples for biomarker analyses.

Disqualifiers

Age younger than 18 years.

Inability or unwillingness to provide written informed consent.

Inability to comply with study procedures or scheduled follow-up.

Presence of any medical, psychiatric, or cognitive condition that, in the opinion of the investigator, would interfere with study participation or interpretation of the study results.

Trial design

Treatments tested in this trial

  • Integrated Precision Medicine Platform

Treatment groups

200 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Fondazione Don Carlo Gnocchi ETS

Lead sponsor

Programma Regionale FESR - Regione Lombardia

Collaborator