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CompletedNCT03696914Updated Oct 5, 2018

Intense Airway Eosinophilia in Asthma

An observational study in Asthma and Eosinophilic Asthma, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-05.

Sponsored by Laval University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
918
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

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Conditions studied

  • Asthma
  • Eosinophilic Asthma

Keywords

  • eosinophil
  • phenotype
  • cluster
  • asthma severity
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In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 918 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Asthmatic subjects from the Quebec city region.

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.

      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

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
918 participants (actual)
Patient registry
No

Groups and cohorts

  • Eosinophilic

    Asthmatic patients showing 3% or more sputum eosinophils

  • Non-eosinophilic

    Asthmatic patients showing less than 3% sputum eosinophils

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What researchers measure

Primary outcomes

  1. Asthma severity according to medication use

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

    Time frame: Baseline

Secondary outcomes

  1. ACSS symptom sub-score

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

    Time frame: Baseline

  2. 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

    Time frame: Baseline

07

Study locations

1 site
  • Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
    Québec, Quebec G1V 4G5, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03696914
Lead sponsor
Laval University
Collaborators
AstraZeneca
Responsible party
Louis-Philippe Boulet (MD, FRCPC, Respirologist, Laval University) — Principal investigator
First posted
Oct 5, 2018
Start date
Jun 6, 2017
Primary completion
Apr 18, 2018
Completion
Aug 3, 2018
Last update
Oct 5, 2018

Study contacts

Louis-Philippe Boulet, MD
principal investigator · IUCPQ-UL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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