Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepolizumab | Drug | Mepolizumab will be prescribed based on physician decision. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At month 12 |
| Percentage of Participants Achieving OCS Sparing Remission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | La Jolla | California | 92037 | United States | ||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Not provided
Not provided
Not provided
Not provided
There will be no masking in this study.
Not provided
| Spirometry |
| Other |
Lung function via spirometry will be collected. |
|
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. |
| 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 | 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 | Baseline and at month 12 |
| Newport Beach |
| California |
| 92663 |
| United States |
| GSK Investigational Site | Aurora | Colorado | 71105 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80923 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06510 | United States |
| GSK Investigational Site | Homestead | Florida | 33032 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32209 | United States |
| GSK Investigational Site | Miami | Florida | 33125 | United States |
| GSK Investigational Site | Plantation | Florida | 33317 | United States |
| GSK Investigational Site | Adairsville | Georgia | 30103 | United States |
| GSK Investigational Site | Columbus | Georgia | 31904 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40509 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | United States |
| GSK Investigational Site | New Orleans | Louisiana | 34452 | United States |
| GSK Investigational Site | Glenn Dale | Maryland | 20769 | United States |
| GSK Investigational Site | Towson | Maryland | 21204 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48103 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Linwood | New Jersey | 08221 | United States |
| GSK Investigational Site | Rochester | New York | 14607 | United States |
| GSK Investigational Site | Schenectady | New York | 12308 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19141 | United States |
| GSK Investigational Site | Union | South Carolina | 29379 | United States |
| GSK Investigational Site | Cypress | Texas | 77429 | United States |
| GSK Investigational Site | Kerrville | Texas | 78028 | United States |
| GSK Investigational Site | McKinney | Texas | 75069 | United States |
| GSK Investigational Site | Kortrijk | 8500 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Calgary | Alberta | T3B0M3 | Canada |
| GSK Investigational Site | Calgary | Alberta | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3L 1Z5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1E2 | Canada |
| GSK Investigational Site | Brest | 29200 | France |
| GSK Investigational Site | Cannes | 06614 | France |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Lyon | 69004 | France |
| GSK Investigational Site | Strasbourg | 67091 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Aachen | 52074 | Germany |
| GSK Investigational Site | Bonn | 53119 | Germany |
| GSK Investigational Site | Darmstadt | 64283 | Germany |
| GSK Investigational Site | Frankfurt | 60389 | Germany |
| GSK Investigational Site | Hohenstein-Ernsttal | 9337 | Germany |
| GSK Investigational Site | Schleswig | 53123 | Germany |
| GSK Investigational Site | Genova | 16132 | Italy |
| GSK Investigational Site | Monserrato CA | 09042 | Italy |
| GSK Investigational Site | Naples | 80131 | Italy |
| GSK Investigational Site | Pieve Di Soligo TV | 131044 | Italy |
| GSK Investigational Site | Roma | 00128 | Italy |
| GSK Investigational Site | Roma | 161 | Italy |
| GSK Investigational Site | Rozzano | 20089 | Italy |
| GSK Investigational Site | Verona | 37126 | Italy |
| GSK Investigational Site | Gifu | 509-6134 | Japan |
| GSK Investigational Site | Kagawa | 760-0018 | Japan |
| GSK Investigational Site | Tokyo | 105-0003 | Japan |
| GSK Investigational Site | Tokyo | 142-8666 | Japan |
| GSK Investigational Site | Tokyo | 173-8606 | Japan |
| GSK Investigational Site | ?Od? | 90-153 | Poland |
| GSK Investigational Site | Gdansk | 80-214 | Poland |
| GSK Investigational Site | Lodz | 92-213 | Poland |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Girona | 17005 | Spain |
| GSK Investigational Site | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C434107 | mepolizumab |
Not provided
Not provided
Not provided