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

October 6, 2023 updated by: CHU de Reims

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Reims, France, 51092
        • Recruiting
        • CHU Reims
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • <18 year-old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2036

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimated)

October 5, 2016

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO16020*

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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