Regulation of CCL18 by Corticosteroids in Severe Asthma

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT03779152
Collaborator
(none)
48
1
96
0.5

Study Details

Study Description

Brief Summary

The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Regulation of CCL18 by Corticosteroids in Severe Asthma
    Actual Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Feb 1, 2017
    Actual Study Completion Date :
    Feb 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    non asthmatic subjects

    intermittent asthmatics

    severe asthmatics sensitive to corticosteroids

    severe asthmatics resistant to corticosteroids

    moderate asthmatics

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between CCL18 rate and asthma phenotypes by elisa test [Baseline: one session]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. control subjects =
    • non-atopic and non-smoking

    • cutting to negative pneumoallergens,

    • Total IgE levels less than 100 ku / L

    • no clinical history of asthma

    • without background treatment

    1. patients with intermittent asthma =
    • being asymptomatic between asthma attacks,

    • with symptoms less than once a week

    • having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical.

    • treated by ß2 mimetics on demand and will not have inhaled corticosteroids.

    1. severe asthma insensitive to corticosteroid therapy =
    • continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone;

    • Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.

    1. Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)]
    • reversibility of FEV1 after treatment with oral corticosteroids.

    • Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.

    1. controlled moderate asthma treated with inhaled corticosteroids <1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.
    Exclusion Criteria:
    • existence of a chronic inflammatory pathology other than asthma

    • active smoking

    • pregnant or lactating women

    • have received oral corticosteroid treatment in the previous 3 weeks,

    • have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Calmette, CHRU Lille France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Benoit Wallaert, MD, PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03779152
    Other Study ID Numbers:
    • 2008/0813
    • 2008-A00370-55
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Dec 21, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 21, 2018