Asthma With Nasal Polyposis

Comparative Characteristics of Asthmatic Patients With and Without Nasal Polyposis: an Observational, Cross-sectional Study of the Quebec Heart and Lung Institute-Laval University Asthma Database.

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Nasal Polyps

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1293

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthmatic patients from the Quebec city region.

Description

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. 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. Stable asthma and asthma medication for at least 4 weeks before data analysis 5. Written informed consent 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:

     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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Asthma with CRSwNP; Asthmatic patients with a diagnosis of CRSwNP
Asthma without CRSwNP; Asthmatic patients without a diagnosis of CRSwNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma severity	Prevalence of asthmatic with CRSwNP in mild, moderate and severe asthma	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sputum inflammatory phenotype	Prevalence of patients with CRSwNP in each inflammatory sub groups: eosinophilic, neutrophilic, paucygranulocytic, Mix	Baseline

Collaborators and Investigators

• Sponsor: Louis-Philippe Boulet
• Collaborators: Genzyme, a Sanofi Company
• Investigators: Principal Investigator: Louis-Philippe Boulet, MD, IUCPQ-UL

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: asthma; chronic rhinosinusitis; nasal polyposis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Polyps; Asthma; Nasal Polyps
• Other Study ID Numbers: CER21489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No