Intense Airway Eosinophilia in Asthma

NCT03696914 | Completed

• 1 other identifier: CÉR21488
• Study Type: observational
• Target: 918
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Eosinophilic Asthma

Keywords

eosinophil; phenotype; cluster; asthma severity

Outcome Measures

Primary Outcomes (1)

• Asthma severity according to medication use

  Prevalence of patients with 3% or more sputum eosinophils in mild, moderate and severe asthma

  Baseline

Secondary Outcomes (2)

• ACSS symptom sub-score

  Baseline

• FEV1 percent predicted

  Baseline

Study Arms (2)

Eosinophilic

Asthmatic patients showing 3% or more sputum eosinophils

Non-eosinophilic

Asthmatic patients showing less than 3% sputum eosinophils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthmatic subjects from the Quebec city region.

You may qualify if:

• Aged 18 years and over
• With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines (36):
• Forced expiratory volume in one second (FEV1) increase by at least 12% (and ≥200 ml) after administration of a bronchodilator
• Current asthma symptoms and a methacholine provocative concentration inducing a 20% fall in FEV1 (PC20) \<16 mg/ml
• 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.

You may not qualify if:

• Any respiratory disease apart from asthma
• 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
• Unstable asthma medication \<4 weeks before data analysis
• Asthma exacerbation (see definition below) \<4 weeks before data analysis
• Respiratory tract infection \<4 weeks before data analysis

Sponsors & Collaborators

• Laval University: lead
• AstraZeneca: collaborator

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Louis-Philippe Boulet, MD

  IUCPQ-UL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Respirologist

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: June 6, 2017
• Primary Completion: April 18, 2018
• Study Completion: August 3, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)