New Diagnostic Approaches in the Management of Inflammatory Lung Diseases

NCT07723638 | Not Yet Recruiting

• 1 other identifier: ALPI
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Idiopathic Pulmonary Fibrosis

Keywords

Biomarkers; COPD; IPF

Outcome Measures

Primary Outcomes (16)

• Innate immunity

  monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)

  Baseline to Month 27

• Adaptive immunity in blood

  caspase 1-5, CTLA-4, TGF-b, PD-1, PDL-1, PDL-2, Galectin9, LAG-3, TIM-3, VISTA, TIGIT, IL-1b, IL-6, IL-10, IL-13, IL-17, IL-18, IL-21, IL-22, IL-23, IL-35 (for all: ng/ml)

  baseline to month 27

• Extracellular matrix proteins from saliva and serum

  Desmosine/isodesmosine, VEGF (for all: ng/ml)

  baseline to month 27

• serum microRNAs

  serum microRNAs by miRNOme analyses (copies/ng)

  baseline to month 27

• Genetic polymorphisms

  KIR; HLA-Cw, VDR, GC1, IL-1β, IL-1Ra, IL-6, IL-10, IL-13, IL-18, TGF-β1, TNF-α polymorphisms (for all: presence or absence

  baseline to month 27

• Salivary Raman spectral fingerprint

  Disease-specific Raman spectral fingerprint obtained from saliva samples using a standardized patented Raman spectroscopy protocol to identify COPD and IPF patient subpopulations.

  baseline to month 27

• Forced Expiratory Volume in 1 second

  Forced Expiratory Volume in 1 second (FEV1) (%)

  baseline to month 27

• VC

  Vital Capacity (VC) (%)

  baseline to month 27

• Total Lung Capacity

  Total Lung Capacity (TLC) (%)

  baseline to month 27

• Inspiratory Capacity

  Inspiratory Capacity (IC) (%)

  baseline to month 27

• Expiratory Reserve Volume

  Expiratory Reserve Volume (ERV) (%)

  baseline to month 27

• Residual Volume

  Residual Volume (RV) (%)

  baseline to month 27

• Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume

  Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)

  baseline to month 27

• Blood gas analysis - PaO2

  PaO2 (mmHg)

  baseline to month 27

• Blood gas analysis - PaCO2

  PaCO2 (mmHg)

  baseline to month 27

• Test 6 minute walk

  Test 6 minute walk (metres)

  baseline to month 27

Secondary Outcomes (7)

• Number of Moderate or Severe Exacerbations

  Baseline to Month 27

• COPD Assessment Test (CAT) Score

  baseline to month 27

• Modified Medical Research Council (mMRC) Dyspnea Scale Score

  baseline to month 27

• Time to first moderate or severe exacerbation

  baseline to month 27

• COPD Assessment Test (CAT)

  baseline to month 27

Study Arms (1)

Integrated Precision Medicine Intervention

EXPERIMENTAL

Other: Integrated Precision Medicine Platform

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.

Integrated Precision Medicine Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness and ability to undergo clinical assessments and scheduled follow-up visits.
• Willingness and ability to use study monitoring devices, including environmental monitoring devices and, where applicable, telemedicine tools.

You may not qualify if:

• 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.
• Participation in another interventional clinical trial that, in the opinion of the investigator, could interfere with the objectives of this study.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi ETS: lead
• Programma Regionale FESR - Regione Lombardia: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial

Study Officials

• Luca Bianchi

  Fondazione Don Gnocchi ETS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Clerici, MD

CONTACT

+390240308244; mario.clerici@unimi.it

Simone Agostini, PhD

CONTACT

+390240308375; sagostini@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 13, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share