Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases

NCT ID: NCT02924818

Last Updated: 2025-02-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2036-11-30

Brief Summary

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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

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Conditions

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Chronic Inflammatory Pulmonary Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chronic Obstructive Pulmonary disease (COPD)

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

Cystic Fibrosis (CF)

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

bronchiectasis

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

Interstitial lung disease (ILD)

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

controls

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

Interventions

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Clinical assessment

Intervention Type OTHER

questionnaires

Intervention Type BEHAVIORAL

pulmonary function test

Intervention Type OTHER

blood test

Intervention Type BIOLOGICAL

microbiology

Intervention Type BIOLOGICAL

histology

Intervention Type BIOLOGICAL

imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 year-old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Reims

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gaëtan Deslée

Role: CONTACT

326787611 ext. 33

Facility Contacts

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Damien JOLLY

Role: primary

326788472 ext. 33

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.

Reference Type DERIVED
PMID: 37990322 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34404378 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33794842 (View on PubMed)

Other Identifiers

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PO16020*

Identifier Type: -

Identifier Source: org_study_id

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