Charcot Leyden Crystals in Pathology

Completed

• Conditions: Asthma

• Registration Number: NCT03999242
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

Detailed Description

In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (\> 3%) and the criteria were extended to those with circulating eosinophilia (\> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-05
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-15
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-06-25
• Last Update Submitted: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Having Charcot Leyden Crystals in a pathological sample

Exclusion Criteria

• Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
'Level of asthma control/severity according to GINA stepwise approach	Baseline (day 0) to Month 12

Secondary Outcome Measures

Name	Time	Method
Cumulative annualized dose of inhaled and systemic corticosteroids	Baseline (day 0) to Month 12	The quantity of corticosteroids consumed during the course of a year.

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France