New Diagnostic Approaches in the Management of Inflammatory Lung Diseases (ALPI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis; Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Other: Integrated Precision Medicine Platform

Detailed Description

The study adopts a prospective cohort design involving patients with Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF), within which a nested, non-randomized interventional substudy on telemedicine monitoring of COPD patients is conducted. This approach combines the investigation of novel molecular, immunological, and genetic/epigenetic biomarkers for personalized medicine with a pragmatic evaluation of a telemonitoring intervention under real-world clinical practice conditions in COPD patients at high risk of exacerbation. The intervention includes home use of the MAIA telemonitoring platform, the FIRST oscillometry device (Restech), based on the Forced Oscillation Technique (FOT) for the assessment of respiratory mechanics, a smart inhaler (Plastiape RS01X) provided by the industrial partner Delim for monitoring adherence to inhaled therapy, and XearPro environmental sensors, supplied by XEarPro S.r.l., for the detection of atmospheric pollutants.

Participants are initially enrolled and followed according to a purely observational approach. A subgroup of the cohort, identified on the basis of predefined clinical and/or operational criteria, is subsequently invited to participate in the interventional component of the study in a non-randomized manner. The effectiveness of the intervention will be assessed using a within-subject comparison, evaluating disease progression during the 12 months preceding enrolment in the interventional substudy and the 12 months following enrolment. This within-patient control design is considered more efficient than the inclusion of a randomized control group, particularly in light of the limited number of participants that can be pragmatically recruited. The remaining cohort members will continue standard follow-up to evaluate the natural course of their disease.

Patients who provide informed consent to participate in the nested interventional substudy will receive detailed instructions on the correct use of the MAIA platform and its associated devices, as well as on the procedures and schedule for completing the study questionnaires. Participants will then be followed longitudinally, with follow-up assessments at 6 and 12 months.

Withdrawal from the study (drop-out) will occur if the patient and/or caregiver becomes unable to continue the protocol-required activities, if there is non-compliance with the protocol timeline (defined as failure to meet two consecutive monthly deadlines), or if informed consent is withdrawn.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simone Agostini, PhD; Phone Number: +390240308375; Email: sagostini@dongnocchi.it
• Study Contact Backup: Name: Mario Clerici, MD; Phone Number: +390240308244; Email: mario.clerici@unimi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Integrated Precision Medicine Intervention

Other: Integrated Precision Medicine Platform; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Moderate or Severe Exacerbations	Number of Moderate or Severe Exacerbations (absolute number)	Baseline to Month 27
COPD Assessment Test (CAT) Score	COPD Assessment Test (CAT) Score (points)	baseline to month 27
Modified Medical Research Council (mMRC) Dyspnea Scale Score	Modified Medical Research Council (mMRC) Dyspnea Scale Score (points)	baseline to month 27
Time to first moderate or severe exacerbation	Time to first moderate or severe exacerbation (days)	baseline to month 27
COPD Assessment Test (CAT)	COPD Assessment Test (CAT) (score)	baseline to month 27
Pulmonary rehabilitation within the previous 12 months	Pulmonary rehabilitation within the previous 12 months (absolute number)	baseline to month 27
Dyspnea severity	Modified Medical Research Council (mMRC) Dyspnea Scale (score)	baseline to month 27

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi ETS
• Collaborators: Programma Regionale FESR - Regione Lombardia
• Investigators: Principal Investigator: Luca Bianchi, Fondazione Don Gnocchi ETS

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): November 13, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Biomarkers; IPF
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Lung Diseases, Interstitial; Pulmonary Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: ALPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No