Regulation of CCL18 by Corticosteroids in Severe Asthma

NCT03779152 | Completed

• 2 other identifiers: 2008/08132008-A00370-55
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Correlation between CCL18 rate and asthma phenotypes by elisa test

  Baseline: one session

Study Arms (5)

non asthmatic subjects

intermittent asthmatics

severe asthmatics sensitive to corticosteroids

severe asthmatics resistant to corticosteroids

moderate asthmatics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients consulting for either asthma or chronic rhinitis and meeting the criteria of the control group.

You may qualify if:

• 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
• 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.
• 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.
• 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)\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Calmette, CHRU

Lille, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Benoit Wallaert, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: February 1, 2009
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)