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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Integrated Precision Medicine Platform
Other interventionParticipants 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Integrated Precision Medicine InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Innate immunity
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
Time frame
Baseline to Month 272
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)
Time frame
baseline to month 273
Extracellular matrix proteins from saliva and serum
Desmosine/isodesmosine, VEGF (for all: ng/ml)
Time frame
baseline to month 274
serum microRNAs
serum microRNAs by miRNOme analyses (copies/ng)
Time frame
baseline to month 27Secondary outcomes
1
Number of Moderate or Severe Exacerbations
Number of Moderate or Severe Exacerbations (absolute number)
Time frame
Baseline to Month 272
COPD Assessment Test (CAT) Score
COPD Assessment Test (CAT) Score (points)
Time frame
baseline to month 273
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Modified Medical Research Council (mMRC) Dyspnea Scale Score (points)
Time frame
baseline to month 274
Time to first moderate or severe exacerbation
Time to first moderate or severe exacerbation (days)
Time frame
baseline to month 27Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi ETS
Lead sponsor
Programma Regionale FESR - Regione Lombardia
Collaborator
Source ClinicalTrials.gov
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