NCT03696914

Completed

Intense Airway Eosinophilia in Asthma

Laval University Source

Compare

Other study identifiers

Sponsor study identifier

CÉR21488

Study Type

observational

Actual enrollment (reported)

918

Locations

1 country

Sites

1

Timeline

Study Start

June 6, 2017

Actual (reported)

Primary Completion

April 18, 2018

Actual (reported)

Study Completion

August 3, 2018

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 918 participants
Study completion date: August 3, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 6, 2017
Actual (reported)
Primary Completion
April 18, 2018
Actual (reported)
Study Completion
August 3, 2018
Actual (reported)
First Submitted
October 2, 2018
Actual (reported)
First Posted
October 5, 2018
Actual (reported)

Last Updated: October 5, 2018
Status Verified: October 2018
Last Update Submitted: October 3, 2018

Conditions

Asthma Eosinophilic Asthma

Keywords

eosinophilphenotypeclusterasthma 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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Asthmatic subjects from the Quebec city region.

You may qualify if:

Aged 18 years and over

Sponsors & Collaborators

Laval University
Otherlead
AstraZeneca
Industrycollaborator

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

MeSH Terms

Conditions

AsthmaPulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

Louis-Philippe Boulet, MD
IUCPQ-UL
PRINCIPAL INVESTIGATOR

Enrollment

918 participants (actual enrollment reported by the registry).

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

Actual (reported)

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NCT02153346

Indirect Cost of Illness Study of Moderate and Severe Asthma in Quebec

Not ApplicableCompleted

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

Contact the study team to confirm eligibility.

Primary Completion

April 18, 2018

Actual (reported)

Study Completion

August 3, 2018

Actual (reported)

Last Updated

October 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03696914
Data provider: ClinicalTrials.gov
Source updated: 2018-10-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:08 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Eosinophilic

Non-eosinophilic

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations