Asthma
Conditions
Keywords
Severe asthma, Eosinophilic phenotype, Oral corticosteroids (OCS), Asthma exacerbations, Clinical remission, NUCALA, Mepolizumab
Brief summary
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).
Interventions
DRUGMepolizumab
Mepolizumab will be prescribed based on physician decision.
OTHERSpirometry
Lung function via spirometry will be collected.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
There will be no masking in this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment. * No NUCALA use in the 6 months prior to enrollment. * Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician. * Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria). * Written informed consent
Exclusion criteria
* Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare) * Participants currently on maintenance OCS or intramuscular corticosteroids. * Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment * Participants participating in an interventional study with a treatment intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Participants Achieving 4-Component Clinical Remission | At month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits | At month 12 | 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. |
| Percentage of Participants Achieving OCS Sparing Remission | At month 12 | 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. |
| Percentage of Participants Achieving 3-Component Clinical Remission | At month 12 | 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 |
| Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score | Baseline and at month 12 | 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 |
Countries
Belgium, Canada, France, Germany, Italy, Japan, Poland, Spain, United States
Outcome results
None listed