Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases
NCT ID: NCT02924818
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
225 participants
INTERVENTIONAL
2016-11-15
2036-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Chronic Obstructive Pulmonary disease (COPD)
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
Cystic Fibrosis (CF)
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
bronchiectasis
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
Interstitial lung disease (ILD)
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
controls
Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
Interventions
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Clinical assessment
questionnaires
pulmonary function test
blood test
microbiology
histology
imaging
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu Reims
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Charon L, Launois C, Perotin JM, Ravoninjatovo B, Mulette P, Ancel J, Guillard T, Muggeo A, Dormoy V, Griffon M, Carre S, Lebargy F, Deslee G, Dury S. Current cough and sputum assessed by the cough and sputum assessment-questionnaire (CASA-Q) is associated with quality of life impairment in cystic fibrosis. BMC Pulm Med. 2023 Nov 21;23(1):457. doi: 10.1186/s12890-023-02701-3.
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.
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.
Other Identifiers
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PO16020*
Identifier Type: -
Identifier Source: org_study_id
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