Pulmonary Disease, Chronic ObstructiveCOPD1722NCT02655302
Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD
A study testing Sample collecting and Lung function measure in people with Pulmonary Disease, Chronic Obstructive and Bacterial Infections, run by University Hospital, Lille at 4 sites in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bacterial Infections
- What is being tested?
- Sample collecting and Lung function measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Jul 2018to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed COPD according GOLD guidelines
- Current or ex-smoker (at least 10 pack-years)
- Hospitalized for COPD exacerbation
Who cannot join
- Asthma or Cystic fibrosis
- No other chronic lung disease
- Solid Tumor unhealed or not considered in remission
- Inhaled drug consumption
- Women of childbearing potential without effective contraception
- Pregnant or breastfeeding women
- Incapable of consent
- Lack of social security coverage
Trial locations and contacts
4 sites in 1 country.
France4 sites
University hospital of Lille
Lille, 59037
Roubaix hospital
Roubaix, 59100
Seclin hospital
Seclin, 59113
Tourcoing hospital
Tourcoing, 59200
About this study
Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover, airway bacterial colonization linked to an increased susceptibility is observed in COPD patients. Effective Th17 immune response is needed to develop a good response against bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22 response to bacteria in COPD leading to airway bacterial colonization and infection.
- Being tested
- Sample collecting, Lung function measure
- Keywords
- Interleukin-17, Interleukin-22, Microbiota, Exacerbations, Immunity, Mucosal
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectingOther
Collect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later.
Lung function measureOther
Measure lung function and follow it during 4 years
| Study group | Role | What they receive |
|---|---|---|
| Bacterial exacerbations | Other | Patients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation. Receives: Other: Sample collecting; Other: Lung function measure |
| Non-bacterial exacerbations | Other | Patients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation. Receives: Other: Sample collecting; Other: Lung function measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure cytokines by ELISA
Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the sputum,between the two groups of patients.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Secondary outcomes (22)
Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the blood.
Measure cytokines by ELISA in the blood at exacerbation and at steady-state. Compare the delta of these cytokines between the two groups of patients.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify IL-17 and IL-22 producing cells in the blood
Identify by flow cytometry, IL-17 and/or IL-22 positive immune cell types in the blood.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify IL-17 and IL-22 producing cells in the sputum
Identify by flow cytometry, IL-17 and/or IL-22 positive immune cell types in the sputum.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of immune cell types in the blood
Quantify by flow cytometry different immune cells in the blood: monocytes, macrophages, B and T cells, innate lymphocytes.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of immune cell types in the sputum
Quantify by flow cytometry different immune cells in the sputum: monocytes, macrophages, B and T cells, innate lymphocytes.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of pro-inflammatory cytokines in blood
Quantify by ELISA Th1 (IL-12, IFN gamma), Th2 (IL-4, IL-5), Th17 (IL-1 beta, IL-6, IL-23, TGF beta), regulatory (IL-10) and pro-inflammatory cytokines (IL-8) in the blood.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of pro-inflammatory cytokines in sputum
Quantify by ELISA Th1 (IL-12, IFN gamma), Th2 (IL-4, IL-5), Th17 (IL-1 beta, IL-6, IL-23, TGF beta), regulatory (IL-10) and pro-inflammatory cytokines (IL-8) in the sputum.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify pathogens linked to the exacerbation
Research of classical bacteria and fungi by usual microbial cultures from sputum and of respiratory virus and non conventional bacteria (Mycoplasma, Legionella, Bordetella pertussis and parapertussis and Chlamydophila pneumoniae) by PCR on nasopharyngeal swab.
Measured: At inclusion (exacerbation)
Identify persistent pathogens at steady-state
Research of classical bacteria and fungi by usual microbial cultures from sputum and of respiratory virus and non conventional bacteria (Mycoplasma, Legionella, Bordetella pertussis and parapertussis and Chlamydophila pneumoniae) by PCR on nasopharyngeal swab.
Measured: Between 8 to 16 weeks (steady-state)
Compare sputum microbiota between exacerbation and steady-state
Metagenomic analysis on sputum
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Compare oxidative stress in the blood between exacerbation and steady-state
Quantification by ELISA in the blood of oxidative stress markers (isoprostane, superoxyde dismutase, 3-nitrotyrosine, peroxyde, catalase).
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of oxidative stress in exhaled condensates
Quantification by ELISA of nitrite species in exhaled condensates.
Measured: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Describe exacerbation phenotype
Collect respiratory symptoms, received treatments and hospitalization duration.
Measured: At inclusion (exacerbation)
Describe environmental exposure
Collect informations on the patient's occupation, occupational exposures and smoking.
Measured: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD clinical phenotype
Collect morphological informations, history of exacerbations
Measured: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD radiological phenotype
Realization of a chest CT scan if not performed during the 2 previous years.
Measured: Between 8 to 16 weeks (steady-state)
Quantify Quality of Life
Realization of the COPD Assessment Test (CAT), a quality of life questionnaire.
Measured: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD treatments
Collect informations on treatments related to COPD including inhaled treatments, influenza and pneumococcal vaccinations, oxygen therapy and respiratory rehabilitation.
Measured: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Measure static lung function
Test the lung function with spirometry and plethysmography repeated annually to measure the decline of respiratory function.
Measured: Between 8 to 16 weeks (steady-state) and annually for 4 years
Measure airway resistances
Measure resistances with the forced oscillation technique.
Measured: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
Measure exercise tolerance
Perform a 6-minute walk-test.
Measured: At inclusion (end of the hospitalization for exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Analysis exercise tolerance
Perform a cardiopulmonary exercise test on a bicycle.
Measured: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study start4 Jul 2018
- Primary completion13 Sep 2023
- Study completion13 Sep 2023
Why it stopped: sponsor decision (COVID)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Bautin, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655302
- Sponsor's protocol ID
- 2013_76
- Other IDs
- 2015-A00190-49
- Acronym
- COPD1722
- Status last verified
- May 2026
- First submitted
- 3 Dec 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT02655302
- Acronym / sponsor ID
- COPD1722 / 2013_76
- Keywords
- Interleukin-17, Interleukin-22, Microbiota, Exacerbations, Immunity, Mucosal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor decision (COVID)
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 14 Jan 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 obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover, airway bacterial colonization linked to an increased susceptibility is observed in COPD patients. Effective Th17 immune response is needed to develop a good response against bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22 response to bacteria in COPD leading to airway bacterial colonization and infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacterial exacerbations | Other | Other: Sample collecting, Other: Lung function measurePatients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation. |
| Non-bacterial exacerbations | Other | Other: Sample collecting, Other: Lung function measurePatients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed COPD according GOLD guidelines
- Current or ex-smoker (at least 10 pack-years)
- Hospitalized for COPD exacerbation
Key exclusion criteria (8 listed)
- Asthma or Cystic fibrosis
- No other chronic lung disease
- Solid Tumor unhealed or not considered in remission
- Inhaled drug consumption
- Women of childbearing potential without effective contraception
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 |
|---|---|---|
| Sample collectingCollect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later. | Other | Bacterial exacerbations, Non-bacterial exacerbations |
| Lung function measureMeasure lung function and follow it during 4 years | Other | Bacterial exacerbations, Non-bacterial exacerbations |
Primary outcome
Measure cytokines by ELISA
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the sputum,between the two groups of patients.
22 secondary outcomes
Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the blood.
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify IL-17 and IL-22 producing cells in the blood
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify IL-17 and IL-22 producing cells in the sputum
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of immune cell types in the blood
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of immune cell types in the sputum
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of pro-inflammatory cytokines in blood
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of pro-inflammatory cytokines in sputum
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify pathogens linked to the exacerbation
Time frame: At inclusion (exacerbation)
Identify persistent pathogens at steady-state
Time frame: Between 8 to 16 weeks (steady-state)
Compare sputum microbiota between exacerbation and steady-state
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Compare oxidative stress in the blood between exacerbation and steady-state
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Quantification of oxidative stress in exhaled condensates
Time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Describe exacerbation phenotype
Time frame: At inclusion (exacerbation)
Describe environmental exposure
Time frame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD clinical phenotype
Time frame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD radiological phenotype
Time frame: Between 8 to 16 weeks (steady-state)
Quantify Quality of Life
Time frame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Describe COPD treatments
Time frame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Measure static lung function
Time frame: Between 8 to 16 weeks (steady-state) and annually for 4 years
Measure airway resistances
Time frame: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
Measure exercise tolerance
Time frame: At inclusion (end of the hospitalization for exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Analysis exercise tolerance
Time frame: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
Results and safety
The study was stopped early (reason given: sponsor decision (COVID)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nathalie Bautin, MD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sample collecting and Lung function measure in people with Pulmonary Disease, Chronic Obstructive and Bacterial Infections, run by University Hospital, Lille at 4 sites 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: sponsor decision (COVID)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure cytokines by ELISA (time frame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.