Chronic Obstructive Pulmonary Disease (COPD)ALPINCT07723638
New Diagnostic Approaches in the Management of Inflammatory Lung Diseases
A study testing Integrated Precision Medicine Platform in people with Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis, run by Fondazione Don Carlo Gnocchi ETS.
Trial summary
Inflammatory lung diseases, including chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), are major causes of morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis
- What is being tested?
- Integrated Precision Medicine Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 13 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- Integrated Precision Medicine Platform
- Keywords
- Biomarkers, COPD, IPF
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Precision Medicine PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Precision Medicine Intervention | Experimental | Not described Receives: Other: Integrated Precision Medicine Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Innate immunity
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
Measured: 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)
Measured: baseline to month 27
Extracellular matrix proteins from saliva and serum
Desmosine/isodesmosine, VEGF (for all: ng/ml)
Measured: baseline to month 27
serum microRNAs
serum microRNAs by miRNOme analyses (copies/ng)
Measured: 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
Measured: 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.
Measured: baseline to month 27
Forced Expiratory Volume in 1 second
Forced Expiratory Volume in 1 second (FEV1) (%)
Measured: baseline to month 27
VC
Vital Capacity (VC) (%)
Measured: baseline to month 27
Total Lung Capacity
Total Lung Capacity (TLC) (%)
Measured: baseline to month 27
Inspiratory Capacity
Inspiratory Capacity (IC) (%)
Measured: baseline to month 27
Expiratory Reserve Volume
Expiratory Reserve Volume (ERV) (%)
Measured: baseline to month 27
Residual Volume
Residual Volume (RV) (%)
Measured: 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) (%)
Measured: baseline to month 27
Blood gas analysis - PaO2
PaO2 (mmHg)
Measured: baseline to month 27
Blood gas analysis - PaCO2
PaCO2 (mmHg)
Measured: baseline to month 27
Test 6 minute walk
Test 6 minute walk (metres)
Measured: baseline to month 27
Secondary outcomes (7)
Number of Moderate or Severe Exacerbations
Number of Moderate or Severe Exacerbations (absolute number)
Measured: Baseline to Month 27
COPD Assessment Test (CAT) Score
COPD Assessment Test (CAT) Score (points)
Measured: baseline to month 27
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Modified Medical Research Council (mMRC) Dyspnea Scale Score (points)
Measured: baseline to month 27
Time to first moderate or severe exacerbation
Time to first moderate or severe exacerbation (days)
Measured: baseline to month 27
COPD Assessment Test (CAT)
COPD Assessment Test (CAT) (score)
Measured: baseline to month 27
Pulmonary rehabilitation within the previous 12 months
Pulmonary rehabilitation within the previous 12 months (absolute number)
Measured: baseline to month 27
Dyspnea severity
Modified Medical Research Council (mMRC) Dyspnea Scale (score)
Measured: baseline to month 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion13 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Programma Regionale FESR - Regione Lombardia
- Responsible party
- Sponsor
- Investigators
- Luca Bianchi, Principal investigator, Fondazione Don Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723638
- Sponsor's protocol ID
- ALPI
- Acronym
- ALPI
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnostic Approaches in the Management of Inflammatory Lung Diseases
- ClinicalTrials.gov ID
- NCT07723638
- Acronym / sponsor ID
- ALPI / ALPI
- Keywords
- Biomarkers, COPD, IPF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Programma Regionale FESR - Regione Lombardia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 13 Nov 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Precision Medicine Intervention | Experimental | Other: Integrated Precision Medicine Platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Precision Medicine PlatformParticipants 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. | Other | Integrated Precision Medicine Intervention |
Primary outcome
Innate immunity
Time frame: Baseline to Month 27
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
Adaptive immunity in blood
Time frame: 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)
Extracellular matrix proteins from saliva and serum
Time frame: baseline to month 27
Desmosine/isodesmosine, VEGF (for all: ng/ml)
serum microRNAs
Time frame: baseline to month 27
serum microRNAs by miRNOme analyses (copies/ng)
Genetic polymorphisms
Time frame: 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
Salivary Raman spectral fingerprint
Time frame: 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.
Forced Expiratory Volume in 1 second
Time frame: baseline to month 27
Forced Expiratory Volume in 1 second (FEV1) (%)
VC
Time frame: baseline to month 27
Vital Capacity (VC) (%)
Total Lung Capacity
Time frame: baseline to month 27
Total Lung Capacity (TLC) (%)
Inspiratory Capacity
Time frame: baseline to month 27
Inspiratory Capacity (IC) (%)
Expiratory Reserve Volume
Time frame: baseline to month 27
Expiratory Reserve Volume (ERV) (%)
Residual Volume
Time frame: baseline to month 27
Residual Volume (RV) (%)
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
Time frame: baseline to month 27
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
Blood gas analysis - PaO2
Time frame: baseline to month 27
PaO2 (mmHg)
Blood gas analysis - PaCO2
Time frame: baseline to month 27
PaCO2 (mmHg)
Test 6 minute walk
Time frame: baseline to month 27
Test 6 minute walk (metres)
7 secondary outcomes
Number of Moderate or Severe Exacerbations
Time frame: Baseline to Month 27
COPD Assessment Test (CAT) Score
Time frame: baseline to month 27
Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time frame: baseline to month 27
Time to first moderate or severe exacerbation
Time frame: baseline to month 27
COPD Assessment Test (CAT)
Time frame: baseline to month 27
Pulmonary rehabilitation within the previous 12 months
Time frame: baseline to month 27
Dyspnea severity
Time frame: baseline to month 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Bianchi principal investigator
Fondazione Don Gnocchi ETS
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Precision Medicine Platform in people with Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Clerici, MD (+390240308244, mario.clerici@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Innate immunity (time frame: Baseline to Month 27). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.