Asthma With Nasal Polyposis

NCT03694847 | Completed

• 1 other identifier: CER21489
• Study Type: observational
• Target: 1,293
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Nasal Polyps

Keywords

asthma; chronic rhinosinusitis; nasal polyposis

Outcome Measures

Primary Outcomes (1)

• Asthma severity

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

  Baseline

Secondary Outcomes (1)

• Sputum inflammatory phenotype

  Baseline

Study Arms (2)

Asthma with CRSwNP

Asthmatic patients with a diagnosis of CRSwNP

Asthma without CRSwNP

Asthmatic patients without a diagnosis of CRSwNP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthmatic patients from the Quebec city region.

You may qualify if:

• \. 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louis-Philippe Boulet: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• 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.

  PMID: 36317421 DERIVED

MeSH Terms

Conditions

Asthma; Nasal Polyps

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Louis-Philippe Boulet, MD

  IUCPQ-UL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, FRCPC, FCCP, respirologist

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: July 19, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)