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OpenTrials
Completed

NCT Number: NCT03999242

Charcot Leyden Crystals in Pathology

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 'Level of asthma control/severity according to GINA stepwise approach

    Time frame: Baseline (day 0)

  2. 'Level of asthma control/severity according to GINA stepwise approach

    Time frame: Baseline (day 0) to Month 12

Secondary outcomes

  1. Cumulative annualized dose of inhaled and systemic corticosteroids

    Time frame: Baseline (day 0) to Month 12

    The quantity of corticosteroids consumed during the course of a year.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples

Acronym: CLCpath

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2019
Registry last updated
Jun 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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