A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 470
- 试验地点
- 1
- 主要终点
- pheno-endotypes of inflammatory respiratory disease
研究概览
简要总结
Chronic inflammatory pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD) and interstitial lung diseases (ILD) are characterised by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognostic features are highly variable and heterogeneous. Several phenotypes have been described within the same pathology, as similar phenotypic traits between different pathologies, or the coexistence of components of several diagnoses in the same patient, suggesting shared underlying mechanisms that could represent new therapeutic targets, beyond the initial medical diagnosis.
The objectives of this prospective study are to analyze the phenotypic characteristics (clinical, demographic, biological, morphological, pathological, and microbiological characteristics) together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes in a cohort of patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD and ILD.
详细描述
The cohort for inflammatory respiratory diseases: from phenotyping to personalised medicine (The PALMIRE project) is a monocentric study conducted at the University Hospital of Reims, France.
Study Population :
Adult patients (>18 year-old) followed at the University Hospital of Reims and diagnosed with asthma, COPD, bronchiectasis, CF, PCD, and IPF will be considered for inclusion. Patients will sign an informed consent for inclusion. Exclusion criteria include "subjects protected by the law" as required by the French authorities. Control patients with no respiratory diseases after clinical and pulmonary function tests assessment will also be included. The expected number of patients included is 470 (Asthma, n=100; COPD, n=150; bronchiectasis, n=50; CF, n=60; PCD, n=30; ILD, n=30; controls, n=50). Inclusion will be conducted for 60 months from July 2025 to July 2030.
Study Procedures:
For all asthma, COPD, bronchiectasis, CF, PCD, and IPF patients included, data will be registered at inclusion, and at follow-up visits for 10 years. Patients will be followed-up as usual care with no specific therapeutic intervention. For control patients, data will be registered at inclusion with no follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Follow-up for one of the following conditions: asthma, COPD, bronchiectasis (DDB), cystic fibrosis (CF), primary ciliary dyskinesia (PCD), or interstitial lung diseases (ILD)
- •Healthy volunteers (controls)
排除标准
- •Subjects protected by law (e.g., legal incapacity)
- •Any condition preventing informed consent or participation
结局指标
主要结局
pheno-endotypes of inflammatory respiratory disease
时间窗: Baseline
Number of subjects in each of the identified pheno-endotypes of inflammatory respiratory disease
次要结局
- Modified Medical Research Council Dyspnea Scale (mMRC dyspnea score)(10 years)
- Forced expiratory volume in one second ( FEV1)(10 years)
- St George's Respiratory Questionnaire (SGRQ score)(10 years)
- Forced Vital Capacity ( FVC )(10 years)
- Total Lung Capacity (TLC)(10 years)
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(10 years)
- 6 minutes walking distance(10 years)
- Asthma Control Test (ACT questionnaire score)(10 years)
- Cough and Sputum Assessment Questionnaire (CASA-Q questionnaire score)(10 years)
- Asthma Quality of Life Questionnaire (AQLQ score)(10 years)