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Intense Airway Eosinophilia in Asthma

Characteristics of the Eosinophilic Asthma Phenotype: an Observational Study in Patients From a Tertiary Care Center With Various Asthma Severities: The Quebec Heart and Lung Institute-Laval University Retrospective Asthma Database Analysis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03696914
Enrollment
918
Registered
2018-10-05
Start date
2017-06-06
Completion date
2018-08-03
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Eosinophilic Asthma

Keywords

eosinophil, phenotype, cluster, asthma severity

Brief summary

In asthma, the type and importance of the inflammatory response in the airways has allows identification of different phenotypes. Of these, one of the most common is eosinophilic asthma, based on induced sputum differential cell count. Patients with severe asthma and an eosinophilic asthma phenotype have different pathophysiological characteristics than those seen in patients with with mild asthma. However, few studies have compared patients with eosinophilic phenotype according to the severity of asthma. In addition, the stability of the phenotype based on the sputum results has been criticized. This study aims to describe the characteristics of patients with eosinophilic asthma phenotype according to the severity of asthma and determine the stability of the phenotype.

Detailed description

Characteristics of asthmatic subjects with sputum eosinophilia will be compared according to asthma severity.

Interventions

None listed

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Laval University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years and over * With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines (36): 1. Forced expiratory volume in one second (FEV1) increase by at least 12% (and ≥200 ml) after administration of a bronchodilator 2. Current asthma symptoms and a methacholine provocative concentration inducing a 20% fall in FEV1 (PC20) \<16 mg/ml 3. A respirologist's current diagnosis of asthma found in the patient's medical report 3. Non-smokers or smokers/ex-smokers defined as someone with a smoking history \<10 pack-years 4. With sputum differential cell count result 5. Considered to receive optimal treatment for their disease (as per current guidelines except for patients included in exploratory objective 1. 6\. Stable asthma and asthma medication for at least 4 weeks before data analysis 7. Written informed consent obtained for inclusion in the database

Exclusion criteria

1. Any respiratory disease apart from asthma 2. Current or ex-smokers should not have a smoking history ≥10 pack-year before data analysis. Patients who administer nicotine in other forms (patches, chew tobacco, e-cigarette, etc.) will be excluded 3. Unstable asthma medication \<4 weeks before data analysis 4. Asthma exacerbation (see definition below) \<4 weeks before data analysis 5. Respiratory tract infection \<4 weeks before data analysis

Design outcomes

Primary

MeasureTime frameDescription
Asthma severity according to medication useBaselinePrevalence of patients with 3% or more sputum eosinophils in mild, moderate and severe asthma

Secondary

MeasureTime frameDescription
ACSS symptom sub-scoreBaselineComparison of asthma control between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils
FEV1 percent predictedBaselineComparison of forced expiratory volume in one second between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026