Eosinophilic AsthmaPLEIADNCT04187976

Eosinophils Endotypes in Chronic Airway Inflammatory Diseases

An observational study of Eosinophilic Asthma and Chronic Sinusitis, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Eosinophilic Asthma, Chronic Sinusitis, Eosinophilic Rhinitis
Type of treatment: Pill or oral medicine
How many people: 70 participants
Where: 1 siteFrance
Study dates: 3 Mar 2020to 30 Oct 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients for the study will be targeted either during hospitalization in Pneumology for uncontrolled asthma patients, during ENT visit for scheduling of sinus surgery (recalcitrant CRSwNP). The healthy subjects are going to be screened in the Clinical Investigation Center of the University Hospital of Lille. Subjects will be contacted by phone after selection in the database.

Who may be able to join

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

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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

Who cannot join

For all groups:
Patients with any other form of secondary CRSwNP (eg, cystic fibrosis, primary ciliary dyskinesia).
Patients with any form of secondary severe asthma (eg (non)eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis)
Patients taking or having taken systemic corticosteroid, leukotriene receptor antagonist, theophylline or long-term macrolide therapy within 1 month prior to sample collections, anti-immunoglobulin E therapy (omalizumab) anti-IL-5/5R or anti IL-4R/anti-IL13 therapies within 6 months before inclusion
Patients followed up for another inflammatory or auto-immune disease
Previous allogeneic bone marrow transplant

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Patients with ongoing sub-cutaneous or sub-lingual anti-allergenic immunotherapies
Patients with active smoking or history of smoking > 10 packages-year for asthma patients
Pregnant, breastfeeding, or lactating women
Non-coverage by the social security insurance
Patient unable to receive informed information
Refusal to sign the consent form
Unwillingness or inability to follow the study procedures, in the opinion of the investigator
Person deprived of the liberty
Person benefiting from a system of legal protection (guardianship…)

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Lille
Lille, 59000

Other trials in France

About this study

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

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.

Read the detailed description

Conditions: Eosinophilic Asthma, Chronic Sinusitis, Eosinophilic Rhinitis
Keywords: Eosinophil, asthma, chronic rhinosinusitis with nasal polyps, biotherapy, endotype
Medical subject headings: Pulmonary Eosinophilia, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04187976
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of blood eosinophils with expression of CD69 marker in patients with uncontrolled asthma alone, recalcitrant chronic rhinosinusitis with nasal polyps (CRSwNP) alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
CD69 expression is measured with flow cytometry on blood eosinophils cell surface.
The percentage of blood eosinophils positive for CD69 is compared between the four groups of patients (uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects)
Measured: Baseline

Secondary outcomes (5)

Percentage of blood eosinophils with expression of HLADR marker in patients with uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
HLADR expression is measured with flow cytometry on blood eosinophils cell surface.
The percentage of blood eosinophils positive for HLADR is compared between the four groups of patients (uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects)
Measured: baseline
Percentage of activated blood eosinophils in patients with uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
Activated status of blood eosinophils is based on concomittant expression of biomarkers ( CD69, HLADR, CCR3) with flow cytometry. The percentage of activated blood eosinophils is compared between the four groups of patients (uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects).
Measured: baseline
Comparison of the percentage of activated eosinophils in blood with the percentage of activated eosinophils in induced sputum in uncontrolled asthma (with or without CRSwNP).
Activated status of eosinophils in blood and in induced sputum is based on concomittant expression of biomarkers ( CD69, HLADR, CCR3) with flow cytometry.
Measured: baseline
Comparison of the percentage of activated eosinophils in blood with the percentage of activated eosinophils in nasal polyps in CRSwNP patients (with or without uncontrolled asthma).
Activated status of eosinophils in blood and in nasal polyps is based on concomittant expression of biomarkers ( CD69, HLADR, CCR3) with flow cytometry.
Measured: baseline
Comparison of qualitative transcriptomic profiles of blood eosinophils in patients with uncontrolled asthma alone, recalcitrant chronic rhinosinusitis with nasal polyps (CRSwNP) alone, uncontrolled asthma and recalcitrant CRSwNP.
Transcriptomic profiles will be compared between CRSwNP with or without uncontrolled asthma and between uncontrolled asthma with or without CRSwNP.
A two-fold differential expression will be used for comparison.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 202030 Oct 2023

First posted5 Dec 2019
Study start3 Mar 2020
Primary completion30 Oct 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Eosinophilic 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-control
Time perspective: Prospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04187976
Sponsor's protocol ID: 2018_81
Other IDs: 2019-A01457-50
Acronym: PLEIAD
Status last verified: May 2026
First submitted: 3 Dec 2019
Last updated: 14 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
SIM0718 Treatment of Asthma Clinical Study
Asthma; Eosinophilic
RecruitingPhase 2
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Active, not recruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Asthma
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA

All Eosinophilic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Peripheral Eosinophils Phenotypes in Airway Inflammatory Diseases: Towards Proper Clustering and Therapeutic Targeting
ClinicalTrials.gov ID: NCT04187976
Acronym / sponsor ID: PLEIAD / 2018_81
Conditions: Eosinophilic Asthma, Chronic Sinusitis, Eosinophilic Rhinitis
Keywords: Eosinophil, asthma, chronic rhinosinusitis with nasal polyps, biotherapy, endotype
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: University Hospital, LilleUniversity, hospital or other
Study start: 3 Mar 2020 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 5 Dec 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.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients for the study will be targeted either during hospitalization in Pneumology for uncontrolled asthma patients, during ENT visit for scheduling of sinus surgery (recalcitrant CRSwNP). The healthy subjects are going to be screened in the Clinical Investigation Center of the University Hospital of Lille. Subjects will be contacted by phone after selection in the database.

Key inclusion criteria (11 listed)

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
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
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

Key exclusion criteria (15 listed)

Patients with any other form of secondary CRSwNP (eg, cystic fibrosis, primary ciliary dyskinesia).
Patients with any form of secondary severe asthma (eg (non)eosinophilic granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis)
Patients taking or having taken systemic corticosteroid, leukotriene receptor antagonist, theophylline or long-term macrolide therapy within 1 month prior to sample collections, anti-immunoglobulin E therapy (omalizumab) anti-IL-5/5R or anti IL-4R/anti-IL13 therapies within 6 months before inclusion
Patients followed up for another inflammatory or auto-immune disease
Previous allogeneic bone marrow transplant

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

Percentage of blood eosinophils with expression of CD69 marker in patients with uncontrolled asthma alone, recalcitrant chronic rhinosinusitis with nasal polyps (CRSwNP) alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
Time frame: Baseline
CD69 expression is measured with flow cytometry on blood eosinophils cell surface. The percentage of blood eosinophils positive for CD69 is compared between the four groups of patients (uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects)

5 secondary outcomes

Percentage of blood eosinophils with expression of HLADR marker in patients with uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
Time frame: baseline
Percentage of activated blood eosinophils in patients with uncontrolled asthma alone, recalcitrant CRSwNP alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects.
Time frame: baseline
Comparison of the percentage of activated eosinophils in blood with the percentage of activated eosinophils in induced sputum in uncontrolled asthma (with or without CRSwNP).
Time frame: baseline
Comparison of the percentage of activated eosinophils in blood with the percentage of activated eosinophils in nasal polyps in CRSwNP patients (with or without uncontrolled asthma).
Time frame: baseline
Comparison of qualitative transcriptomic profiles of blood eosinophils in patients with uncontrolled asthma alone, recalcitrant chronic rhinosinusitis with nasal polyps (CRSwNP) alone, uncontrolled asthma and recalcitrant CRSwNP.
Time frame: baseline

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 14 May 2026.

Related trials for Eosinophilic Asthma

Active, not recruitingPhase 3
SIM0718 Treatment of Asthma Clinical Study
Asthma; Eosinophilic
RecruitingPhase 2
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Active, not recruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Asthma
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA

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.

Cécile Chenivess, MD,PhD principal investigator

University Hospital, Lille

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 Eosinophilic Asthma and Chronic Sinusitis, run by University Hospital, Lille 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 11 inclusion and 15 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 14 May 2026. 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?

Percentage of blood eosinophils with expression of CD69 marker in patients with uncontrolled asthma alone, recalcitrant chronic rhinosinusitis with nasal polyps (CRSwNP) alone, uncontrolled asthma and recalcitrant CRSwNP and in healthy subjects. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04187976.

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 14 May 2026.