Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07274631
Acronym
PALMIRE
Enrollment
470
Registered
2025-12-10
Start date
2025-09-15
Completion date
2040-09-15
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchiectasis, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Primary Ciliary Dyskinesia

Keywords

Chronic obstructive pulmonary disease, Asthma, Bronchiectasis, Cystic fibrosis, Primary ciliary dyskinesia, Airway microbiota, Airway epithelium, Remodeling, Exposome

Brief summary

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

Non applicable

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pheno-endotypes of inflammatory respiratory diseaseBaselineNumber of subjects in each of the identified pheno-endotypes of inflammatory respiratory disease

Secondary

MeasureTime frame
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)10 years
6 minutes walking distance10 years
Modified Medical Research Council Dyspnea Scale (mMRC dyspnea score)10 years
Asthma Control Test (ACT questionnaire score)10 years
Total Lung Capacity (TLC)10 years
Asthma Quality of Life Questionnaire (AQLQ score)10 years
St George's Respiratory Questionnaire (SGRQ score)10 years
Forced expiratory volume in one second ( FEV1)10 years
Forced Vital Capacity ( FVC )10 years
Cough and Sputum Assessment Questionnaire (CASA-Q questionnaire score)10 years

Countries

France

Contacts

CONTACTJeanne-Marie PEROTIN-COLLARD
jmperotin-collard@chu-reims.fr03 10 73 67 63
CONTACTGaëtan DESLEE
gdeslee@chu-reims.fr03 26 78 76 11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026