Asthma With Nasal Polyposis

NCT ID: NCT03694847

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1293 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-19
• Study Completion Date: 2018-09-15

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.

Conditions

Asthma; Nasal Polyps

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Asthma with CRSwNP

Asthmatic patients with a diagnosis of CRSwNP

No interventions assigned to this group

Asthma without CRSwNP

Asthmatic patients without a diagnosis of CRSwNP

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Louis-Philippe Boulet

OTHER

Sponsor Role: lead

Responsible Party

Louis-Philippe Boulet

MD, FRCPC, FCCP, respirologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Louis-Philippe Boulet, MD

Role: PRINCIPAL_INVESTIGATOR

IUCPQ-UL

Locations

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

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36317421 (View on PubMed)

Other Identifiers

CER21489

Identifier Type: -

Identifier Source: org_study_id