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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Simone Agostini, PhD
- Numero di telefono: +390240308375
- Email: sagostini@dongnocchi.it
Backup dei contatti dello studio
- Nome: Mario Clerici, MD
- Numero di telefono: +390240308244
- Email: mario.clerici@unimi.it
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Integrated Precision Medicine Intervention
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Innate immunity
Lasso di tempo: Baseline to Month 27
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monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
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Baseline to Month 27
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Adaptive immunity in blood
Lasso di tempo: baseline to month 27
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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)
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baseline to month 27
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Extracellular matrix proteins from saliva and serum
Lasso di tempo: baseline to month 27
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Desmosine/isodesmosine, VEGF (for all: ng/ml)
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baseline to month 27
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serum microRNAs
Lasso di tempo: baseline to month 27
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serum microRNAs by miRNOme analyses (copies/ng)
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baseline to month 27
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Genetic polymorphisms
Lasso di tempo: baseline to month 27
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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
|
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Salivary Raman spectral fingerprint
Lasso di tempo: baseline to month 27
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Disease-specific Raman spectral fingerprint obtained from saliva samples using a standardized patented Raman spectroscopy protocol to identify COPD and IPF patient subpopulations.
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baseline to month 27
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Forced Expiratory Volume in 1 second
Lasso di tempo: baseline to month 27
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Forced Expiratory Volume in 1 second (FEV1) (%)
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baseline to month 27
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VC
Lasso di tempo: baseline to month 27
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Vital Capacity (VC) (%)
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baseline to month 27
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Total Lung Capacity
Lasso di tempo: baseline to month 27
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Total Lung Capacity (TLC) (%)
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baseline to month 27
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Inspiratory Capacity
Lasso di tempo: baseline to month 27
|
Inspiratory Capacity (IC) (%)
|
baseline to month 27
|
|
Expiratory Reserve Volume
Lasso di tempo: baseline to month 27
|
Expiratory Reserve Volume (ERV) (%)
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baseline to month 27
|
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Residual Volume
Lasso di tempo: baseline to month 27
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Residual Volume (RV) (%)
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baseline to month 27
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Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Lasso di tempo: baseline to month 27
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Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
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baseline to month 27
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Blood gas analysis - PaO2
Lasso di tempo: baseline to month 27
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PaO2 (mmHg)
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baseline to month 27
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Blood gas analysis - PaCO2
Lasso di tempo: baseline to month 27
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PaCO2 (mmHg)
|
baseline to month 27
|
|
Test 6 minute walk
Lasso di tempo: baseline to month 27
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Test 6 minute walk (metres)
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baseline to month 27
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Moderate or Severe Exacerbations
Lasso di tempo: Baseline to Month 27
|
Number of Moderate or Severe Exacerbations (absolute number)
|
Baseline to Month 27
|
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COPD Assessment Test (CAT) Score
Lasso di tempo: baseline to month 27
|
COPD Assessment Test (CAT) Score (points)
|
baseline to month 27
|
|
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Lasso di tempo: baseline to month 27
|
Modified Medical Research Council (mMRC) Dyspnea Scale Score (points)
|
baseline to month 27
|
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Time to first moderate or severe exacerbation
Lasso di tempo: baseline to month 27
|
Time to first moderate or severe exacerbation (days)
|
baseline to month 27
|
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COPD Assessment Test (CAT)
Lasso di tempo: baseline to month 27
|
COPD Assessment Test (CAT) (score)
|
baseline to month 27
|
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Pulmonary rehabilitation within the previous 12 months
Lasso di tempo: baseline to month 27
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Pulmonary rehabilitation within the previous 12 months (absolute number)
|
baseline to month 27
|
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Dyspnea severity
Lasso di tempo: baseline to month 27
|
Modified Medical Research Council (mMRC) Dyspnea Scale (score)
|
baseline to month 27
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Luca Bianchi, Fondazione Don Gnocchi ETS
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattia cronica
- Attributi della malattia
- Malattie delle vie respiratorie
- Malattie polmonari
- Malattie polmonari, ostruttive
- Malattie polmonari, interstiziale
- Fibrosi polmonare
- Condizioni patologiche, segni e sintomi
- Malattia polmonare, cronica ostruttiva
- Fibrosi Polmonare Idiopatica
Altri numeri di identificazione dello studio
- ALPI
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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