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Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (RINNOPARI)

C

CHU de Reims

Status

Enrolling

Conditions

Chronic Inflammatory Pulmonary Diseases

Treatments

Biological: blood test
Other: Clinical assessment
Other: imaging
Behavioral: questionnaires
Other: pulmonary function test
Biological: histology
Biological: microbiology

Study type

Interventional

Funder types

Other

Identifiers

NCT02924818
PO16020*

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • <18 year-old

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

225 participants in 5 patient groups

Chronic Obstructive Pulmonary disease (COPD)
Experimental group
Treatment:
Behavioral: questionnaires
Other: imaging
Biological: blood test
Other: Clinical assessment
Biological: histology
Other: pulmonary function test
Biological: microbiology
Cystic Fibrosis (CF)
Experimental group
Treatment:
Behavioral: questionnaires
Other: imaging
Biological: blood test
Other: Clinical assessment
Biological: histology
Other: pulmonary function test
Biological: microbiology
bronchiectasis
Experimental group
Treatment:
Behavioral: questionnaires
Other: imaging
Biological: blood test
Other: Clinical assessment
Biological: histology
Other: pulmonary function test
Biological: microbiology
Interstitial lung disease (ILD)
Experimental group
Treatment:
Behavioral: questionnaires
Other: imaging
Biological: blood test
Other: Clinical assessment
Biological: histology
Other: pulmonary function test
Biological: microbiology
controls
Experimental group
Treatment:
Behavioral: questionnaires
Other: imaging
Biological: blood test
Other: Clinical assessment
Biological: histology
Other: pulmonary function test
Biological: microbiology

Trial contacts and locations

1

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Central trial contact

Gaëtan Deslée

Data sourced from clinicaltrials.gov

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