Peripheral Eosinophils Phenotypes in Airway Inflammatory Diseases: Towards Proper Clustering and Therapeutic Targeting

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are frequently described as unified airway inflammatory diseases. Both heavily impacts quality of life with substantial productivity loss. They share the same pathophysiologic pattern based upon proTh2 immune response with blood eosinophils recruitment. Eosinophils are the major actor of persistent mucosal inflammation by promoting their own survival, by attracting other inflammatory cells and by producing cytotoxic proteins involved in mucosal remodeling. Promising anti-Th2 therapeutic approaches (i.e.anti-IgE, anti-interleukin 5 (IL-5), anti-IL-4, anti-IL-13) are considered as effective alternative options to long-term corticosteroid treatment. Their advantage in recalcitrant CRSwNP is under consideration. Moreover, we still need to delineate the good responders to improve theirs indications. The objective is to assess blood eosinophil immunophenotypes in asthma or CRSwNP. Flow cytometric expression of activation markers on eosinophil membrane will be compared with a group of healthy subjects. Innovative data on eosinophil involvement in airway diseases will be obtained. The major outcome will be to depict patients' endotypes for a better selection of immunotherapies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ For all groups:

⁃ Social insured patient

⁃ Patient willing to comply with all procedures of the study and its duration

⁃ Provision of signed and dated informed consent form prior to any study specific procedure

⁃ For Group 1:

• Patients with moderate to severe uncontrolled asthma, confirmed by relevant clinical symptoms and proven variable airway obstruction, and assessed by an expert pulmonologist according to spirometry criteria (absolute and weighed Forced Expiratory Volume (FEV) and Forced Vital Capacity (FVC) before and after 2 test),(see CRF for details). Uncontrolled asthma will be defined by an ACQ score ≥ 1.5. or acute exacerbation

⁃ For Groups 2 and 3:

⁃ Patients with medically refractory bilateral sino-nasal polyposis requiring sinus surgery, according to an expert rhinologist. CRSwNP diagnosis is based on the presence of bilateral nasal polyps from both side of middle turbinates on nasoendoscopy and bilateral sinus opacification on CT scan. Briefly, CRSwNP is considered as refractory when symptoms are still not controlled after 3 courses of oral corticosteroid and double dose of nasal corticosteroid during the last 12 months

⁃ Patients with both uncontrolled asthma and recalcitrant CRSwNP with or without concomitant aspirin-exacerbated respiratory disease (AERD) (group 3)

⁃ For Group 4:

• Healthy subjects without any airway disease or any atopic status, as assessed by a questionnaire and a medical examination

Locations
Other Locations
France
CHU Lille
Recruiting
Lille
Contact Information
Primary
Cécile Chenivesse, MD,PhD
cecile.chenivesse@chru-lille.fr
03 20 44 59 48
Time Frame
Start Date: March 3, 2020
Estimated Completion Date: March 2024
Participants
Target number of participants: 80
Treatments
Patients with moderate to severe uncontrolled asthma
Patients with moderate to severe uncontrolled asthma defined on clinical assessment and spirometric criteria. Non controlled asthma is considered when ACQ score ≥ 1.5 or in case of acute exacerbation
Patients with recalcitrant CRSwNP requiring sinus surgery
The medical failure in CRSwNP is defined as persistent disease in spite of 3 courses of oral corticosteroid and double dose of local corticoid over 12 months
Patients with concomitant CRSwNP and uncontrolled asthma
Patients with concomitant CRSwNP and moderate to severe uncontrolled asthma
Healthy subjects
Patients without any airway inflammatory disease or atopy
Authors
Cécile Chenivesse, Cécile Chenivess
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov

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