A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non applicable.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease, Asthma, Bronchiectasis, Cystic Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Other Non applicable
Non applicable
Primary outcome measures
- pheno-endotypes of inflammatory respiratory disease [Time frame: Baseline]
Secondary outcome measures (10)
- Forced expiratory volume in one second ( FEV1) [Time frame: 10 years]
- Forced Vital Capacity ( FVC ) [Time frame: 10 years]
- Total Lung Capacity (TLC) [Time frame: 10 years]
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Time frame: 10 years]
- 6 minutes walking distance [Time frame: 10 years]
- Modified Medical Research Council Dyspnea Scale (mMRC dyspnea score) [Time frame: 10 years]
- Asthma Control Test (ACT questionnaire score) [Time frame: 10 years]
- Cough and Sputum Assessment Questionnaire (CASA-Q questionnaire score) [Time frame: 10 years]
- Asthma Quality of Life Questionnaire (AQLQ score) [Time frame: 10 years]
- St George's Respiratory Questionnaire (SGRQ score) [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Subjects protected by law (e.g., legal incapacity)
- Any condition preventing informed consent or participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chu Reims — Reims
Identifiers
NCT: NCT07274631 · PL25060*