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OpenTrials
Completed

NCT Number: NCT03694847

Asthma With Nasal Polyposis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Québec, Quebec, G1V 4G5, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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. 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

  • 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

Treatment and study plan

Primary outcomes

  1. Asthma severity

    Time frame: Baseline

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

Secondary outcomes

  1. Sputum inflammatory phenotype

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Louis-Philippe Boulet

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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