Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases

Not Applicable

Recruiting

• Conditions: Chronic Inflammatory Pulmonary Diseases
• Interventions: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging

• Registration Number: NCT02924818
• Lead Sponsor: CHU de Reims

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-04
• Study First Posted: 2016-10-05
• Study Start: 2016-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-11
• Study Completion: 2036-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD

Exclusion Criteria

• <18 year-old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interstitial lung disease (ILD)	blood test	-
controls	blood test	-
controls	histology	-
controls	questionnaires	-
bronchiectasis	histology	-
Interstitial lung disease (ILD)	Clinical assessment	-
Interstitial lung disease (ILD)	pulmonary function test	-
Interstitial lung disease (ILD)	imaging	-
Interstitial lung disease (ILD)	microbiology	-
Interstitial lung disease (ILD)	histology	-
Interstitial lung disease (ILD)	questionnaires	-
controls	Clinical assessment	-
Chronic Obstructive Pulmonary disease (COPD)	Clinical assessment	-
Chronic Obstructive Pulmonary disease (COPD)	microbiology	-
Cystic Fibrosis (CF)	histology	-
bronchiectasis	questionnaires	-
bronchiectasis	microbiology	-
bronchiectasis	imaging	-
Cystic Fibrosis (CF)	microbiology	-
Cystic Fibrosis (CF)	imaging	-
bronchiectasis	blood test	-
Chronic Obstructive Pulmonary disease (COPD)	blood test	-
Cystic Fibrosis (CF)	Clinical assessment	-
controls	pulmonary function test	-
controls	microbiology	-
controls	imaging	-
bronchiectasis	pulmonary function test	-
Cystic Fibrosis (CF)	questionnaires	-
Cystic Fibrosis (CF)	pulmonary function test	-
Chronic Obstructive Pulmonary disease (COPD)	questionnaires	-
Chronic Obstructive Pulmonary disease (COPD)	pulmonary function test	-
Chronic Obstructive Pulmonary disease (COPD)	histology	-
Chronic Obstructive Pulmonary disease (COPD)	imaging	-
Cystic Fibrosis (CF)	blood test	-
bronchiectasis	Clinical assessment	-

Primary Outcome Measures

Name	Time	Method
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample	up to 10 years

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France