This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
336
Mepolizumab will be prescribed based on physician decision.
Lung function via spirometry will be collected.
Percentage (%) of Participants Achieving 4-Component Clinical Remission
4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
Time frame: At month 12
Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
Time frame: At month 12
Percentage of Participants Achieving OCS Sparing Remission
OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
Time frame: At month 12
Percentage of Participants Achieving 3-Component Clinical Remission
3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT
Time frame: At month 12
Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability
Time frame: Baseline and at month 12
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