Clinical trial NCT02655302: Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD
Official title: Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Bacterial Infections
Keywords: Interleukin-17
Interleukin-22
Microbiota
Exacerbations
Immunity
Mucosal
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure cytokines by ELISA
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Secondary outcomes:
measure: Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the blood.
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Identify IL-17 and IL-22 producing cells in the blood
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Identify IL-17 and IL-22 producing cells in the sputum
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Quantification of immune cell types in the blood
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Quantification of immune cell types in the sputum
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Quantification of pro-inflammatory cytokines in blood
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Quantification of pro-inflammatory cytokines in sputum
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Identify pathogens linked to the exacerbation
timeFrame: At inclusion (exacerbation)
measure: Identify persistent pathogens at steady-state
timeFrame: Between 8 to 16 weeks (steady-state)
measure: Compare sputum microbiota between exacerbation and steady-state
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Compare oxidative stress in the blood between exacerbation and steady-state
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Quantification of oxidative stress in exhaled condensates
timeFrame: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
measure: Describe exacerbation phenotype
timeFrame: At inclusion (exacerbation)
measure: Describe environmental exposure
timeFrame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Describe COPD clinical phenotype
timeFrame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Describe COPD radiological phenotype
timeFrame: Between 8 to 16 weeks (steady-state)
measure: Quantify Quality of Life
timeFrame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Describe COPD treatments
timeFrame: At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Measure static lung function
timeFrame: Between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Measure airway resistances
timeFrame: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
measure: Measure exercise tolerance
timeFrame: At inclusion (end of the hospitalization for exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years
measure: Analysis exercise tolerance
timeFrame: Between 8 to 16 weeks (steady-state) and at 2 and 4 years
Other outcomes:
Locations:
city: Lille
country: France
facility: University hospital of Lille
city: Roubaix
country: France
facility: Roubaix hospital
city: Seclin
country: France
facility: Seclin hospital
city: Tourcoing
country: France
facility: Tourcoing hospital
Study officials:
affiliation: University Hospital, Lille
name: Nathalie Bautin, MD
role: PRINCIPAL_INVESTIGATOR
References: