ClinicalTrials.gg
CompletedNCT03694847Updated Oct 3, 2018

Asthma With Nasal Polyposis

An observational study in Asthma and Nasal Polyps, sponsored by Louis-Philippe Boulet. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by Louis-Philippe Boulet · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
1,293
Ages
18 Years and older
Sex
All
01

Study summary

Asthma is often associated with various comorbidities that may influence its clinical expression. Among those, chronic rhinosinusitis with nasal polyposis (CRSwNP) is observed in 5% of cases. Asthmatic patients with CRSwNP appear to have more severe and poorly controlled asthma, as well as greater bronchial and systemic inflammation, especially those using inhaled corticosteroids as control medication. However, this remains to be validated. In the last decade, there has been interest labeled for phenotyping of asthma and CRSwNP. However, there is scarce data on the phenotype of asthma with CRSwNP.

This study aims to describe the phenotype of asthmatic patients with CRSwNP according to the clinical, physiological and inflammatory characteristics and whether there is a more severe phenotype related to the dose of inhaled corticosteroids and the percentage of induced sputum eosinophils.

Read the detailed description

This study will compare the characteristics of asthmatic patients with CRSwNP with those without CRSwNP.

02

Conditions studied

  • Asthma
  • Nasal Polyps

Keywords

  • asthma
  • chronic rhinosinusitis
  • nasal polyposis
03

In context

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 1,293 is above the median of 158 across 1,250 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Louis-Philippe Boulet is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Study population

Asthmatic patients from the Quebec city region.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Aged 18 years and over 2. With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines:

      1. (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. Stable asthma and asthma medication for at least 4 weeks before data analysis 5. Written obtained for inclusion in the database

        Patients with CRSwNP

        1. With a proven diagnosis of CRSwNP, based on endoscopy and defined as the presence of endoscopically visible bilateral polyps growing from the middle meatus with or without involvement of the nasal cavities

Exclusion criteria

Exclusion Criteria:

  1. Any respiratory disease apart from asthma and CRSwNP
  2. Current or ex-smokers should not have a smoking history ≥10 pack-years 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 index date
  4. Asthma exacerbation (see definition below) \<4 weeks before index date
  5. Respiratory tract infection \<4 weeks before index date
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
1,293 participants (actual)
Patient registry
No

Groups and cohorts

  • Asthma with CRSwNP

    Asthmatic patients with a diagnosis of CRSwNP

  • Asthma without CRSwNP

    Asthmatic patients without a diagnosis of CRSwNP

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What researchers measure

Primary outcomes

  1. Asthma severity

    Prevalence of asthmatic with CRSwNP in mild, moderate and severe asthma

    Time frame: Baseline

Secondary outcomes

  1. Sputum inflammatory phenotype

    Prevalence of patients with CRSwNP in each inflammatory sub groups: eosinophilic, neutrophilic, paucygranulocytic, Mix

    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
08

References and documents

Publications

  • Birs I, Boulay ME, Bertrand M, Cote A, Boulet LP. Heterogeneity of asthma with nasal polyposis phenotypes: A cluster analysis. Clin Exp Allergy. 2023 Jan;53(1):52-64. doi: 10.1111/cea.14247. Epub 2022 Nov 1. PubMed 36317421 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03694847
Lead sponsor
Louis-Philippe Boulet
Responsible party
Louis-Philippe Boulet (MD, FRCPC, FCCP, respirologist, Laval University) — Sponsor-investigator
First posted
Oct 3, 2018
Start date
Jul 19, 2018
Primary completion
Sep 15, 2018
Completion
Sep 15, 2018
Last update
Oct 3, 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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Discussion

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