Chronic Inflammatory Pulmonary DiseasesRINNOPARINCT02924818
Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases
A study testing Clinical assessment, questionnaires and pulmonary function test in people with Chronic Inflammatory Pulmonary Diseases, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Pulmonary Diseases
- What is being tested?
- Clinical assessment, questionnaires and pulmonary function test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to Nov 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD
Who cannot join
- <18 year-old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: 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.
Read more
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
- Being tested
- Clinical assessment, questionnaires, pulmonary function test, blood test, microbiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
questionnairesBehavioural
pulmonary function testOther
blood testBiological
microbiologyBiological
histologyBiological
imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary disease (COPD) | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging |
| Cystic Fibrosis (CF) | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging |
| bronchiectasis | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging |
| Interstitial lung disease (ILD) | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging |
| controls | Experimental | Not described Receives: Other: Clinical assessment; Behavioral: questionnaires; Other: pulmonary function test; Biological: blood test; Biological: microbiology; Biological: histology; Other: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Measured: baseline
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start15 Nov 2016
- Primary completionNov 2026 (estimated)
- Study completionNov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924818
- Sponsor's protocol ID
- PO16020*
- Acronym
- RINNOPARI
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2016
- Last updated
- 24 Feb 2025
- Results posted
- No
Publications
Dupuis A, Thierry A, Perotin JM, Ancel J, Dormoy V, Dury S, Deslee G, Launois C. Obesity Impact on Dyspnea in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2024 Jul 22;19:1695-1706. doi: 10.2147/COPD.S450366. eCollection 2024.
PubMed 39070800Charon 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.
PubMed 37990322Dury 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.
PubMed 34404378Mulette 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.
PubMed 33794842
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort for Research and Innovation in Chronic Inflammatory Respiratory Diseases: The RINNOPARI Project
- ClinicalTrials.gov ID
- NCT02924818
- Acronym / sponsor ID
- RINNOPARI / PO16020*
- Conditions
- Chronic Inflammatory Pulmonary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2036 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>18 year-old) with COPD, CF, bronchiectasis or ILD
Key exclusion criteria (1 listed)
- <18 year-old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessment | Other | Chronic Obstructive Pulmonary disease (COPD), Cystic Fibrosis (CF), Interstitial lung disease (ILD), bronchiectasis, controls |
| questionnaires | Behavioural | 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 |
Primary outcome
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Time frame: baseline
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 39070800Dupuis A, Thierry A, Perotin JM, Ancel J, Dormoy V, Dury S, Deslee G, Launois C. Obesity Impact on Dyspnea in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2024 Jul 22;19:1695-1706. doi: 10.2147/COPD.S450366. eCollection 2024.
- Derived from this study: PubMed 37990322Charon 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.
- Derived from this study: PubMed 34404378Dury 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.
- Derived from this study: PubMed 33794842Mulette 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical assessment, questionnaires and pulmonary function test in people with Chronic Inflammatory Pulmonary Diseases, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaëtan Deslée (326787611 ext. 33, gdeslee@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific measurements: cytokines (Th1, Th2, Th17, Tc1, Tc2, Tc17) measurements in blood sample (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924818, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.