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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03696914
Other study ID # CÉR21488
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 6, 2017
Est. completion date August 3, 2018

Study information

Verified date October 2018
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 918
Est. completion date August 3, 2018
Est. primary completion date April 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec Québec Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma severity according to medication use Prevalence of patients with 3% or more sputum eosinophils in mild, moderate and severe asthma Baseline
Secondary ACSS symptom sub-score Comparison of asthma control between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils Baseline
Secondary FEV1 percent predicted Comparison of forced expiratory volume in one second between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils Baseline
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