Regulation of CCL18 by Corticosteroids in Severe Asthma

Asthma Clinical Trial

— CCL18  

Official title:

Regulation of CCL18 by Corticosteroids in Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779152
• Other study ID #: 2008/0813
• Secondary ID: 2008-A00370-55
• Status: Completed
• Start date: February 2009
• Est. completion date: February 2017

Study information

• Verified date: December 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

2. 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.

3. 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.

4. 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.

5. 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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Hôpital Calmette, CHRU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between CCL18 rate and asthma phenotypes by elisa test		Baseline: one session