Intense Airway Eosinophilia in Asthma

NCT ID: NCT03696914

Last Updated: 2018-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

918 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-06

Study Completion Date

2018-08-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Eosinophilic Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eosinophilic

Asthmatic patients showing 3% or more sputum eosinophils

No interventions assigned to this group

Non-eosinophilic

Asthmatic patients showing less than 3% sputum eosinophils

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Louis-Philippe Boulet

MD, FRCPC, Respirologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

IUCPQ-UL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Québec, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CÉR21488

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.