Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases

Study Overview
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Brief Summary
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Chronic inflammatory pulmonary diseases including chronic obstructive pulmonary disease (COPD), interstitial lung diseases (ILD), bronchiectasis, and cystic fibrosis (CF) are characterized by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognosis features are highly variable and heterogeneous. A precise phenotyping is a key-element to better understanding the pathophysiology of these chronic inflammatory diseases and to develop innovative treatment strategies. The objectives of this prospective study is to analyze the clinical, demographic, biological, morphological, pathological, and microbiological characteristics in a cohort of patients diagnosed with COPD, ILD, bronchiectasis, and CF. The associations between clinical, demographic, biological, morphological, pathological, and microbiological features will be assessed. The Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (the RINNOPARI Project: Recherche et Innovation en Pathologie Respiratoire Inflammatoire) is a monocentric study conducted at the University Hospital of Reims, France. Adult patients (>18 year-old) followed at the University Hospital of Reims and diagnosed with COPD, ILD, bronchiectasis, or CF 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 be also included. The expected number of patients included is 225 (COPD, n=100; CF, n=25; bronchiectasis, n=25; ILD, n=25; controls, n=50). Inclusion will be conducted for 36 months from September 2016 (9/30/2016) to September 2019 (9/30/2019). For all COPD, ILD, bronchiectasis, and CF 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. 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. This study should help to better characterize clinical, demographic, biological, morphological, pathological, and microbiological characteristics and phenotypes in chronic inflammatory respiratory diseases.

Official Title
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Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project

Conditions
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Chronic Inflammatory Pulmonary Diseases

Intervention / Treatment
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* Other: Clinical assessment
* Behavioral: questionnaires
* Other: pulmonary function test
* Biological: blood test
* Biological: microbiology
* Biological: histology
* Other: imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD Exclusion Criteria: <18 year-old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chronic Obstructive Pulmonary disease (COPD)<br> | Other: Clinical assessment<br> <br> Behavioral: questionnaires<br> <br> Other: pulmonary function test<br> <br> Biological: blood test<br> <br> Biological: microbiology<br> <br> Biological: histology<br> <br> Other: imaging<br> <br> |
| Experimental: Cystic Fibrosis (CF)<br> | Other: Clinical assessment<br> <br> Behavioral: questionnaires<br> <br> Other: pulmonary function test<br> <br> Biological: blood test<br> <br> Biological: microbiology<br> <br> Biological: histology<br> <br> Other: imaging<br> <br> |
| Experimental: bronchiectasis<br> | Other: Clinical assessment<br> <br> Behavioral: questionnaires<br> <br> Other: pulmonary function test<br> <br> Biological: blood test<br> <br> Biological: microbiology<br> <br> Biological: histology<br> <br> Other: imaging<br> <br> |
| Experimental: Interstitial lung disease (ILD)<br> | Other: Clinical assessment<br> <br> Behavioral: questionnaires<br> <br> Other: pulmonary function test<br> <br> Biological: blood test<br> <br> Biological: microbiology<br> <br> Biological: histology<br> <br> Other: imaging<br> <br> |
| Experimental: controls<br> | Other: Clinical assessment<br> <br> Behavioral: questionnaires<br> <br> Other: pulmonary function test<br> <br> Biological: blood test<br> <br> Biological: microbiology<br> <br> Biological: histology<br> <br> Other: imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample |  | baseline | 
| Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample |  | up to 10 years |