AsthmaCLCpathNCT03999242
Charcot Leyden Crystals in Pathology
An observational study of Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 15 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients seen at our institution
Who may be able to join
- Having Charcot Leyden Crystals in a pathological sample
Who cannot join
- Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples
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
Read the 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.
- Conditions
- Asthma
- Keywords
- nasal polyposis, rhinosinusitis, Charcot Leyden Crystals, Eosinophils
- Medical subject headings
- Asthma, Nasal Polyps, Rhinosinusitis
What is being measured
The primary outcome is the main question the study is designed to answer.
'Level of asthma control/severity according to GINA stepwise approach
Measured: Baseline (day 0)
'Level of asthma control/severity according to GINA stepwise approach
Measured: Baseline (day 0) to Month 12
Secondary outcomes (1)
Cumulative annualized dose of inhaled and systemic corticosteroids
The quantity of corticosteroids consumed during the course of a year.
Measured: Baseline (day 0) to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Apr 2019
- Primary completion1 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999242
- Sponsor's protocol ID
- RECHMPL19_0256
- Acronym
- CLCpath
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples
- ClinicalTrials.gov ID
- NCT03999242
- Acronym / sponsor ID
- CLCpath / RECHMPL19_0256
- Conditions
- Asthma
- Keywords
- nasal polyposis, rhinosinusitis, Charcot Leyden Crystals, Eosinophils
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients seen at our institution
Key inclusion criteria (1 listed)
- Having Charcot Leyden Crystals in a pathological sample
Key exclusion criteria (1 listed)
- Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
'Level of asthma control/severity according to GINA stepwise approach
Time frame: Baseline (day 0)
'Level of asthma control/severity according to GINA stepwise approach
Time frame: Baseline (day 0) to Month 12
1 secondary outcome
Cumulative annualized dose of inhaled and systemic corticosteroids
Time frame: Baseline (day 0) to Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Bourdin, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'Level of asthma control/severity according to GINA stepwise approach (time frame: Baseline (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.