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临床试验/NCT03694847
NCT03694847已完成不适用

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 个研究点 分布在 1 个国家目标入组 1,293 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,293
试验地点
1
主要终点
Asthma severity

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Asthma severity

时间窗: Baseline

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

次要结局

  • Sputum inflammatory phenotype(Baseline)

研究者

发起方
Louis-Philippe Boulet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Louis-Philippe Boulet

MD, FRCPC, FCCP, respirologist

Laval University

研究点 (1)

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