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

U

University Hospital, Lille

Status

Enrolling

Conditions

Pulmonary Disease, Chronic Obstructive
Bacterial Infections

Treatments

Other: Sample collecting
Other: Lung function measure

Study type

Interventional

Funder types

Other

Identifiers

NCT02655302
2013_76
2015-A00190-49 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Bacterial exacerbations
Other group
Description:
Patients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation.
Treatment:
Other: Lung function measure
Other: Sample collecting
Non-bacterial exacerbations
Other group
Description:
Patients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation.
Treatment:
Other: Lung function measure
Other: Sample collecting

Trial contacts and locations

4

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Central trial contact

Olivier Le Rouzic, MD; Nathalie Bautin, MD

Data sourced from clinicaltrials.gov

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