NCT03999242

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
Last Updated

June 26, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 20, 2019

Last Update Submit

June 25, 2019

Conditions

Asthma

Keywords

nasal polyposisrhinosinusitisCharcot Leyden CrystalsEosinophils

Outcome Measures

Primary Outcomes (2)

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

    Baseline (day 0)

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

    Baseline (day 0) to Month 12

Secondary Outcomes (1)

  • Cumulative annualized dose of inhaled and systemic corticosteroids

    Baseline (day 0) to Month 12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients seen at our institution

You may qualify if:

  • Having Charcot Leyden Crystals in a pathological sample

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bronchial biopsies, sinonasal biopsies, BAL

MeSH Terms

Conditions

AsthmaNasal PolypsRhinosinusitis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus Diseases

Study Officials

  • Arnaud Bourdin, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 26, 2019

Study Start

April 1, 2019

Primary Completion

May 1, 2019

Study Completion

May 15, 2019

Last Updated

June 26, 2019

Record last verified: 2019-05

Locations

FR(1)