Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04650503
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-10-14
Brief Title:
Follow-up of Mild Eosinophilic Asthma
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Clinical Outcome of Mild to Very-mild Asthma With High Sputum Eosinophils andor High Genetic Risk Score a Prospective Longitudinal Study
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asthma is a chronic respiratory disease affecting approximately 10 of the population the majority of patients with very mild to mild asthma Asthma is characterized primarily by the presence of symptoms clinical variables reversible airway obstruction and airway hyperresponsiveness Inflammation is a key factor in the pathophysiology of the disease Eosinophilic inflammation is the most common type However in the literature it is usually associated with more severe and difficult to control asthma Although mortality associated with asthma has drastically decreased in recent years several events still occur Strangely enough these frequently affect mild asthmatics Although there is still a misunderstanding in relation to these events the most recent practice guides have recommended an approach based on the use of inhaled corticosteroids ICS in all including mild asthmatics This change of therapeutic cap is still debated but indicates a need for new studies in this population Recently the investigators demonstrated that a subgroup of asthma patients with mild asthma had a eosinophilia The evolution of this subgroup without bronchial obstruction or respiratory symptoms remains unknown Indeed it seems imperative to determine the fate of these subjects in comparison with asthma mild non-eosinophilic since it could be a subgroup at risk of poor outcome The objective of this study will be to examine the course of asthma in very mild to mild asthma patients who exhibit eosinophilic inflammation of the respiratory tract compared to noneosinophilic subjects
This will be a prospective observational longitudinal study Participants for whom a result of induced sputum showing an eosinophil level greater than or equal to 3 was observed at least 1 year ago will be contacted to participate in the study They will be matched for age gender and duration of asthma to subjects without eosinophilia These subjects will not be on bronchial anti-inflammatory medication They will have a complete evaluation including respiratory function tests a methacholine challenge and sputum induction They will also complete questionnaires on controlling their asthma and exacerbations
This will be a prospective observational longitudinal study Participants for whom a result of induced sputum showing an eosinophil level greater than or equal to 3 was observed at least 1 year ago will be contacted to participate in the study They will be matched for age gender and duration of asthma to subjects without eosinophilia These subjects will not be on bronchial anti-inflammatory medication They will have a complete evaluation including respiratory function tests a methacholine challenge and sputum induction They will also complete questionnaires on controlling their asthma and exacerbations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None