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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Simone Agostini, PhD
- Telefonní číslo: +390240308375
- E-mail: sagostini@dongnocchi.it
Studijní záloha kontaktů
- Jméno: Mario Clerici, MD
- Telefonní číslo: +390240308244
- E-mail: mario.clerici@unimi.it
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Integrated Precision Medicine Intervention
|
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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Innate immunity
Časové okno: Baseline to Month 27
|
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
|
Baseline to Month 27
|
|
Adaptive immunity in blood
Časové okno: baseline to month 27
|
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
Časové okno: baseline to month 27
|
Desmosine/isodesmosine, VEGF (for all: ng/ml)
|
baseline to month 27
|
|
serum microRNAs
Časové okno: baseline to month 27
|
serum microRNAs by miRNOme analyses (copies/ng)
|
baseline to month 27
|
|
Genetic polymorphisms
Časové okno: baseline to month 27
|
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
Časové okno: baseline to month 27
|
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
Časové okno: baseline to month 27
|
Forced Expiratory Volume in 1 second (FEV1) (%)
|
baseline to month 27
|
|
VC
Časové okno: baseline to month 27
|
Vital Capacity (VC) (%)
|
baseline to month 27
|
|
Total Lung Capacity
Časové okno: baseline to month 27
|
Total Lung Capacity (TLC) (%)
|
baseline to month 27
|
|
Inspiratory Capacity
Časové okno: baseline to month 27
|
Inspiratory Capacity (IC) (%)
|
baseline to month 27
|
|
Expiratory Reserve Volume
Časové okno: baseline to month 27
|
Expiratory Reserve Volume (ERV) (%)
|
baseline to month 27
|
|
Residual Volume
Časové okno: baseline to month 27
|
Residual Volume (RV) (%)
|
baseline to month 27
|
|
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Časové okno: baseline to month 27
|
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
|
baseline to month 27
|
|
Blood gas analysis - PaO2
Časové okno: baseline to month 27
|
PaO2 (mmHg)
|
baseline to month 27
|
|
Blood gas analysis - PaCO2
Časové okno: baseline to month 27
|
PaCO2 (mmHg)
|
baseline to month 27
|
|
Test 6 minute walk
Časové okno: baseline to month 27
|
Test 6 minute walk (metres)
|
baseline to month 27
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Moderate or Severe Exacerbations
Časové okno: Baseline to Month 27
|
Number of Moderate or Severe Exacerbations (absolute number)
|
Baseline to Month 27
|
|
COPD Assessment Test (CAT) Score
Časové okno: baseline to month 27
|
COPD Assessment Test (CAT) Score (points)
|
baseline to month 27
|
|
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Časové okno: baseline to month 27
|
Modified Medical Research Council (mMRC) Dyspnea Scale Score (points)
|
baseline to month 27
|
|
Time to first moderate or severe exacerbation
Časové okno: baseline to month 27
|
Time to first moderate or severe exacerbation (days)
|
baseline to month 27
|
|
COPD Assessment Test (CAT)
Časové okno: baseline to month 27
|
COPD Assessment Test (CAT) (score)
|
baseline to month 27
|
|
Pulmonary rehabilitation within the previous 12 months
Časové okno: baseline to month 27
|
Pulmonary rehabilitation within the previous 12 months (absolute number)
|
baseline to month 27
|
|
Dyspnea severity
Časové okno: baseline to month 27
|
Modified Medical Research Council (mMRC) Dyspnea Scale (score)
|
baseline to month 27
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Luca Bianchi, Fondazione Don Gnocchi ETS
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ALPI
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