New Diagnostic Approaches in the Management of Inflammatory Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Innate immunity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Innate immunity
时间窗: Baseline to Month 27
monocytes, macrophages, neutrophils, dendritic cells, NLRP-3 inflammasome (for all: % of cells)
Adaptive immunity in blood
时间窗: 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
时间窗: baseline to month 27
Desmosine/isodesmosine, VEGF (for all: ng/ml)
serum microRNAs
时间窗: baseline to month 27
serum microRNAs by miRNOme analyses (copies/ng)
Genetic polymorphisms
时间窗: 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
时间窗: 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
时间窗: baseline to month 27
Forced Expiratory Volume in 1 second (FEV1) (%)
VC
时间窗: baseline to month 27
Vital Capacity (VC) (%)
Total Lung Capacity
时间窗: baseline to month 27
Total Lung Capacity (TLC) (%)
Inspiratory Capacity
时间窗: baseline to month 27
Inspiratory Capacity (IC) (%)
Expiratory Reserve Volume
时间窗: baseline to month 27
Expiratory Reserve Volume (ERV) (%)
Residual Volume
时间窗: baseline to month 27
Residual Volume (RV) (%)
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume
时间窗: baseline to month 27
Diffusing Capacity of the Lung for Carbon Monoxide / Alveolar Volume (DLCO/AV) (%)
Blood gas analysis - PaO2
时间窗: baseline to month 27
PaO2 (mmHg)
Blood gas analysis - PaCO2
时间窗: baseline to month 27
PaCO2 (mmHg)
Test 6 minute walk
时间窗: baseline to month 27
Test 6 minute walk (metres)
次要结局
- Number of Moderate or Severe Exacerbations(Baseline to Month 27)
- COPD Assessment Test (CAT) Score(baseline to month 27)
- Modified Medical Research Council (mMRC) Dyspnea Scale Score(baseline to month 27)
- Time to first moderate or severe exacerbation(baseline to month 27)
- COPD Assessment Test (CAT)(baseline to month 27)
- Pulmonary rehabilitation within the previous 12 months(baseline to month 27)
- Dyspnea severity(baseline to month 27)