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Clinical Trials/NCT03694847
NCT03694847
Completed
Not Applicable

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.

Louis-Philippe Boulet1 site in 1 country1,293 target enrollmentJuly 19, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Louis-Philippe Boulet
Enrollment
1293
Locations
1
Primary Endpoint
Asthma severity
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
July 19, 2018
End Date
September 15, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Louis-Philippe Boulet
Responsible Party
Sponsor Investigator
Principal Investigator

Louis-Philippe Boulet

MD, FRCPC, FCCP, respirologist

Laval University

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years and over
  • With a proven diagnosis of asthma as defined by one of the above criteria of current guidelines:
  • 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
  • Non-smokers or smokers/ex-smokers defined as someone with a smoking history \<10 pack-years
  • Stable asthma and asthma medication for at least 4 weeks before data analysis
  • Written informed consent obtained for inclusion in the database
  • Patients with CRSwNP
  • 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

  • Any respiratory disease apart from asthma and CRSwNP
  • 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
  • Unstable asthma medication \<4 weeks before index date
  • Asthma exacerbation (see definition below) \<4 weeks before index date
  • Respiratory tract infection \<4 weeks before index date

Outcomes

Primary Outcomes

Asthma severity

Time Frame: Baseline

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

Secondary Outcomes

  • Sputum inflammatory phenotype(Baseline)

Study Sites (1)

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