NCT02655302

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2018Jul 2028

First Submitted

Initial submission to the registry

December 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 4, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

10 years

First QC Date

December 3, 2015

Last Update Submit

January 26, 2023

Conditions

Pulmonary Disease, Chronic ObstructiveBacterial Infections

Keywords

Interleukin-17Interleukin-22MicrobiotaExacerbationsImmunityMucosal

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)

  • Identify IL-17 and IL-22 producing cells 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

    At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)

  • Quantification of immune cell types in the blood

    At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)

  • Quantification of immune cell types in the sputum

    At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)

  • +17 more secondary outcomes

Study Arms (2)

Bacterial exacerbations

OTHER

Patients with at least 10\^7 UFC/ml bacteria in their sputum during their first COPD exacerbation.

Other: Sample collectingOther: Lung function measure

Non-bacterial exacerbations

OTHER

Patients without detected bacteria or below 10\^7 UFC/ml in sputum during their first COPD exacerbation.

Other: Sample collectingOther: Lung function measure

Interventions

Sample collectingOTHER

Collect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later.

Bacterial exacerbationsNon-bacterial exacerbations
Lung function measureOTHER

Measure lung function and follow it during 4 years

Bacterial exacerbationsNon-bacterial exacerbations

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University hospital of Lille

Lille, 59037, France

RECRUITING

Roubaix hospital

Roubaix, 59100, France

RECRUITING

Seclin hospital

Seclin, 59113, France

NOT YET RECRUITING

Tourcoing hospital

Tourcoing, 59200, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBacterial Infections

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial Infections and MycosesInfections

Study Officials

  • Nathalie Bautin, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Bautin, MD

CONTACT

320444318nathalie.bautin@chru-lille.fr

Olivier Le Rouzic, MD

CONTACT

320444318olivier.lerouzic@chru-lille.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

December 3, 2015

First Posted

January 14, 2016

Study Start

July 4, 2018

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)