Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases

NCT02924818 | Recruiting

• 1 other identifier: PO16020*
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Pulmonary Diseases

Outcome Measures

Primary Outcomes (2)

• Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample

  baseline

• Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample

  up to 10 years

Study Arms (5)

Chronic Obstructive Pulmonary disease (COPD)

EXPERIMENTAL

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

Cystic Fibrosis (CF)

EXPERIMENTAL

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

bronchiectasis

EXPERIMENTAL

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

Interstitial lung disease (ILD)

EXPERIMENTAL

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

controls

EXPERIMENTAL

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

Interventions

Clinical assessment OTHER

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

questionnaires BEHAVIORAL

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

pulmonary function test OTHER

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

blood test BIOLOGICAL

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

microbiology BIOLOGICAL

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

histology BIOLOGICAL

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

imaging OTHER

Chronic Obstructive Pulmonary disease (COPD); Cystic Fibrosis (CF); Interstitial lung disease (ILD); bronchiectasis; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<18 year-old

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 37990322 DERIVED

• 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.

  PMID: 34404378 DERIVED

• 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.

  PMID: 33794842 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires; Respiratory Physiological Phenomena; Hematologic Tests; Shadowing Technique, Histology; X-Rays

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Circulatory and Respiratory Physiological Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Histological Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Gaëtan Deslée

CONTACT

326787611; gdeslee@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 5, 2016
• Study Start: November 15, 2016
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2036
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

FR (1)