- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07274631
A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine (PALMIRE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jeanne-Marie PEROTIN-COLLARD
- Phone Number: 0033 03 10 73 67 63
- Email: jmperotin-collard@chu-reims.fr
Study Contact Backup
- Name: Gaëtan DESLEE
- Phone Number: 0033 03 26 78 76 11
- Email: gdeslee@chu-reims.fr
Study Locations
-
-
-
Reims, France, 51092
- Recruiting
- Chu Reims
-
Contact:
- Damien JOLLY
- Phone Number: 33 326788472
- Email: djolly@chu-reims.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pheno-endotypes of inflammatory respiratory disease
Time Frame: Baseline
|
Number of subjects in each of the identified pheno-endotypes of inflammatory respiratory disease
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Forced expiratory volume in one second ( FEV1)
Time Frame: 10 years
|
10 years
|
|
Forced Vital Capacity ( FVC )
Time Frame: 10 years
|
10 years
|
|
Total Lung Capacity (TLC)
Time Frame: 10 years
|
10 years
|
|
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time Frame: 10 years
|
10 years
|
|
6 minutes walking distance
Time Frame: 10 years
|
10 years
|
|
Modified Medical Research Council Dyspnea Scale (mMRC dyspnea score)
Time Frame: 10 years
|
10 years
|
|
Asthma Control Test (ACT questionnaire score)
Time Frame: 10 years
|
10 years
|
|
Cough and Sputum Assessment Questionnaire (CASA-Q questionnaire score)
Time Frame: 10 years
|
10 years
|
|
Asthma Quality of Life Questionnaire (AQLQ score)
Time Frame: 10 years
|
10 years
|
|
St George's Respiratory Questionnaire (SGRQ score)
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ciliopathies
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Genetic Diseases, Inborn
- Immune System Diseases
- Respiratory Tract Diseases
- Digestive System Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Pancreatic Diseases
- Congenital Abnormalities
- Otorhinolaryngologic Diseases
- Abnormalities, Multiple
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Ciliary Motility Disorders
- Cystic Fibrosis
- Bronchiectasis
Other Study ID Numbers
- PL25060*
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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