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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03694847

Enrollment

1293

Registered

2018-10-03

Start date

2018-07-19

Completion date

2018-09-15

Last updated

2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Nasal Polyps

Keywords

asthma, chronic rhinosinusitis, nasal polyposis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results