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NCT Number: NCT03696914

Intense Airway Eosinophilia in Asthma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Québec, Quebec, G1V 4G5, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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.
  • 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

  • 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

Treatment and study plan

Primary outcomes

  1. Asthma severity according to medication use

    Time frame: Baseline

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

Secondary outcomes

  1. ACSS symptom sub-score

    Time frame: Baseline

    Comparison of asthma control between patients with 3% or more sputum eosinophils and patients with less than 3% sputum eosinophils

  2. FEV1 percent predicted

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2018
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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