New Diagnostic Approaches in the Management of Inflammatory Lung Diseases

Sponsor
Fondazione Don Carlo Gnocchi ETS
Study ID
NCT07723638
Status
Not Yet Recruiting

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Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Integrated Precision Medicine Platform — OTHER
    Participants will undergo an integrated precision medicine intervention for inflammatory lung diseases, including multi-omics biomarker assessment, clinical and environmental monitoring, and telemedicine-supported follow-up. The intervention includes the collection of biological samples for biomarker profiling, assessment of indoor and outdoor environmental exposures, and continuous monitoring of clinical and environmental parameters. Where applicable, participants will receive a precision inhalation medical device designed to optimize drug delivery. Data from biomarker analyses, monitoring devices, and the telemedicine platform will be integrated to support personalized disease management and the early identification of disease exacerbations.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Nov 13, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Integrated Precision Medicine Intervention

Primary Outcome Measure

Innate immunity [ Time Frame: Baseline to Month 27 ]

Central Contacts

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