Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD (COPD1722)

May 19, 2026 updated by: University Hospital, Lille
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lille, France, 59037
        • University Hospital of Lille
      • Roubaix, France, 59100
        • Roubaix hospital
      • Seclin, France, 59113
        • Seclin hospital
      • Tourcoing, France, 59200
        • Tourcoing hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed COPD according GOLD guidelines
  • Current or ex-smoker (at least 10 pack-years)
  • Hospitalized for COPD exacerbation

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Bacterial exacerbations
Patients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation.
Other: Sample collecting
Collect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later.
Other: Lung function measure
Measure lung function and follow it during 4 years
Other: Non-bacterial exacerbations
Patients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation.
Other: Sample collecting
Collect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later.
Other: Lung function measure
Measure lung function and follow it during 4 years

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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 by flow cytometry, IL-17 and/or IL-22 positive immune cell types in the blood.
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)
Identify by flow cytometry, IL-17 and/or IL-22 positive immune cell types in the sputum.
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)
Quantify by flow cytometry different immune cells in the blood: monocytes, macrophages, B and T cells, innate lymphocytes.
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)
Quantify by flow cytometry different immune cells in the sputum: monocytes, macrophages, B and T cells, innate lymphocytes.
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)
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.
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)
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.
At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Identify pathogens linked to the exacerbation
Time Frame: At inclusion (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.
At inclusion (exacerbation)
Identify persistent pathogens at steady-state
Time Frame: Between 8 to 16 weeks (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.
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)
Metagenomic analysis on sputum
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 by ELISA in the blood of oxidative stress markers (isoprostane, superoxyde dismutase, 3-nitrotyrosine, peroxyde, catalase).
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)
Quantification by ELISA of nitrite species in exhaled condensates.
At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Describe exacerbation phenotype
Time Frame: At inclusion (exacerbation)
Collect respiratory symptoms, received treatments and hospitalization duration.
At inclusion (exacerbation)
Describe environmental exposure
Time Frame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
Collect informations on the patient's occupation, occupational exposures and smoking.
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
Collect morphological informations, history of exacerbations
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)
Realization of a chest CT scan if not performed during the 2 previous years.
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
Realization of the COPD Assessment Test (CAT), a quality of life questionnaire.
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
Collect informations on treatments related to COPD including inhaled treatments, influenza and pneumococcal vaccinations, oxygen therapy and respiratory rehabilitation.
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
Test the lung function with spirometry and plethysmography repeated annually to measure the decline of respiratory function.
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 resistances with the forced oscillation technique.
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
Perform a 6-minute walk-test.
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
Perform a cardiopulmonary exercise test on a bicycle.
Between 8 to 16 weeks (steady-state) and at 2 and 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathalie Bautin, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013_76
  • 2015-A00190-49 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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