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

NCT ID: NCT02655302

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2028-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Bacterial Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Bacterial exacerbations

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

Group Type OTHER

Sample collecting

Intervention Type OTHER

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

Lung function measure

Intervention Type OTHER

Measure lung function and follow it during 4 years

Non-bacterial exacerbations

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

Group Type OTHER

Sample collecting

Intervention Type OTHER

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

Lung function measure

Intervention Type OTHER

Measure lung function and follow it during 4 years

Interventions

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Sample collecting

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

Intervention Type OTHER

Lung function measure

Measure lung function and follow it during 4 years

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Bautin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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University hospital of Lille

Lille, , France

Site Status RECRUITING

Roubaix hospital

Roubaix, , France

Site Status RECRUITING

Seclin hospital

Seclin, , France

Site Status NOT_YET_RECRUITING

Tourcoing hospital

Tourcoing, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nathalie Bautin, MD

Role: CONTACT

[email protected]
320444318 ext. +33

Olivier Le Rouzic, MD

Role: CONTACT

[email protected]
320444318 ext. +33

Facility Contacts

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Nathalie Bautin, MD

Role: primary

[email protected]

Olivier Le Rouzic, MD

Role: backup

[email protected]

Olivier Le Rouzic, MD

Role: primary

[email protected]

Olivier Le Rouzic, MD

Role: primary

[email protected]

Olivier Le Rouzic, MD

Role: primary

[email protected]

Other Identifiers

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2015-A00190-49

Identifier Type: OTHER

Identifier Source: secondary_id

2013_76

Identifier Type: -

Identifier Source: org_study_id

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