Intense Airway Eosinophilia in Asthma

Completed

• Conditions: Asthma; Eosinophilic Asthma

• Registration Number: NCT03696914
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2017-06-06
• Primary Completion: 2018-04-18
• Study Completion: 2018-08-03
• Status Verified: 2018-10
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-05
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 918

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma severity according to medication use	Baseline	Prevalence of patients with 3% or more sputum eosinophils in mild, moderate and severe asthma

Secondary Outcome Measures

Name	Time	Method
FEV1 percent predicted	Baseline	Comparison of forced expiratory volume in one second between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils
ACSS symptom sub-score	Baseline	Comparison of asthma control between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils

Trial Locations

Locations (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada