Идёт набор NCT07274631

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

— Наблюдательное Chronic Obstructive Pulmonary Disease Asthma Bronchiectasis Cystic Fibrosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Non applicable.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis, Cystic Fibrosis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Подробное описание

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.

The recorded data will include demographics, history of respiratory disease and comorbidities, respiratory symptoms, results of lung function tests and CT-scan, microbiological and pathological features of respiratory sampling when performed.

Data Analysis:

Data will be registered in a centralized anonymized database. The characteristics of the patients will be described as mean and standard deviation for quantitative data and as number and percentages for qualitative data. Comparisons and associations between groups and variables will be analyzed by Student, Wilcoxon, Chi2, Fischer exact, and Spearman tests as applicable. A p\<0.05 will be considered as significant. Multivariate and longitudinal statistical models will be used to identify clusters of patients with shared endotypes. Machine learning approaches will be employed to integrate multi-omic data and generate predictive models for disease trajectories and treatment responses.

Significance:

This study should help better understand the pathogenesis and heterogeneity of chronic respiratory diseases by integrating the analysis of phenotypic and endotypic characteristics of patients.

Вмешательства

Другое Non applicable
Non applicable

Первичные конечные точки

pheno-endotypes of inflammatory respiratory disease [Срок оценки: Baseline]

Вторичные конечные точки (10)

Forced expiratory volume in one second ( FEV1) [Срок оценки: 10 years]
Forced Vital Capacity ( FVC ) [Срок оценки: 10 years]
Total Lung Capacity (TLC) [Срок оценки: 10 years]
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Срок оценки: 10 years]
6 minutes walking distance [Срок оценки: 10 years]
Modified Medical Research Council Dyspnea Scale (mMRC dyspnea score) [Срок оценки: 10 years]
Asthma Control Test (ACT questionnaire score) [Срок оценки: 10 years]
Cough and Sputum Assessment Questionnaire (CASA-Q questionnaire score) [Срок оценки: 10 years]
Asthma Quality of Life Questionnaire (AQLQ score) [Срок оценки: 10 years]
St George's Respiratory Questionnaire (SGRQ score) [Срок оценки: 10 years]

Критерии участия

Критерии включения

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)