Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases (RINNOPARI)
Primary Purpose
Chronic Inflammatory Pulmonary Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Inflammatory Pulmonary Diseases
Eligibility Criteria
Inclusion Criteria:
- Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD
Exclusion Criteria:
- <18 year-old
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Chronic Obstructive Pulmonary disease (COPD)
Cystic Fibrosis (CF)
bronchiectasis
Interstitial lung disease (ILD)
controls
Arm Description
Outcomes
Primary Outcome Measures
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02924818
Brief Title
Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases
Acronym
RINNOPARI
Official Title
Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Pulmonary Diseases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic Obstructive Pulmonary disease (COPD)
Arm Type
Experimental
Arm Title
Cystic Fibrosis (CF)
Arm Type
Experimental
Arm Title
bronchiectasis
Arm Type
Experimental
Arm Title
Interstitial lung disease (ILD)
Arm Type
Experimental
Arm Title
controls
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Clinical assessment
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Type
Other
Intervention Name(s)
pulmonary function test
Intervention Type
Biological
Intervention Name(s)
blood test
Intervention Type
Biological
Intervention Name(s)
microbiology
Intervention Type
Biological
Intervention Name(s)
histology
Intervention Type
Other
Intervention Name(s)
imaging
Primary Outcome Measure Information:
Title
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Time Frame
baseline
Title
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD
Exclusion Criteria:
<18 year-old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaëtan Deslée
Phone
326787611
Ext
33
Email
gdeslee@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
34404378
Citation
Dury S, Perotin JM, Ravoninjatovo B, Llerena C, Ancel J, Mulette P, Griffon M, Carre S, Perrin A, Lebargy F, Deslee G, Launois C. Identifying specific needs in adult cystic fibrosis patients: a pilot study using a custom questionnaire. BMC Pulm Med. 2021 Aug 18;21(1):270. doi: 10.1186/s12890-021-01613-4.
Results Reference
derived
PubMed Identifier
33794842
Citation
Mulette P, Ravoninjatovo B, Guguen C, Barbe C, Ancel J, Dury S, Dumazet A, Perdu D, Perotin JM, Guillard T, Lebargy F, Deslee G, Launois C. Insomnia in adults with cystic fibrosis: strong association with anxiety/depression and impaired quality of life. BMC Pulm Med. 2021 Apr 1;21(1):108. doi: 10.1186/s12890-021-01473-y.
Results Reference
derived
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Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases
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