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

21. juli 2026 opdateret af: Fondazione Don Carlo Gnocchi ETS

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Integrated Precision Medicine Intervention
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Innate immunity
Tidsramme: Baseline to Month 27
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
Baseline to Month 27
Adaptive immunity in blood
Tidsramme: 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
Tidsramme: baseline to month 27
Desmosine/isodesmosine, VEGF (for all: ng/ml)
baseline to month 27
serum microRNAs
Tidsramme: baseline to month 27
serum microRNAs by miRNOme analyses (copies/ng)
baseline to month 27
Genetic polymorphisms
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline to month 27
Forced Expiratory Volume in 1 second (FEV1) (%)
baseline to month 27
VC
Tidsramme: baseline to month 27
Vital Capacity (VC) (%)
baseline to month 27
Total Lung Capacity
Tidsramme: baseline to month 27
Total Lung Capacity (TLC) (%)
baseline to month 27
Inspiratory Capacity
Tidsramme: baseline to month 27
Inspiratory Capacity (IC) (%)
baseline to month 27
Expiratory Reserve Volume
Tidsramme: baseline to month 27
Expiratory Reserve Volume (ERV) (%)
baseline to month 27
Residual Volume
Tidsramme: baseline to month 27
Residual Volume (RV) (%)
baseline to month 27
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Tidsramme: baseline to month 27
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
baseline to month 27
Blood gas analysis - PaO2
Tidsramme: baseline to month 27
PaO2 (mmHg)
baseline to month 27
Blood gas analysis - PaCO2
Tidsramme: baseline to month 27
PaCO2 (mmHg)
baseline to month 27
Test 6 minute walk
Tidsramme: baseline to month 27
Test 6 minute walk (metres)
baseline to month 27

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Don Carlo Gnocchi ETS

Samarbejdspartnere

Programma Regionale FESR - Regione Lombardia

Efterforskere

  • Ledende efterforsker: Luca Bianchi, Fondazione Don Gnocchi ETS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

13. november 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALPI

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Kliniske forsøg med Idiopatisk lungefibrose

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