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This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-drug interventional group | Other | All enrolled participants will provide a blood sample, spirometry , and feedback on their severe asthma symptoms via questionnaires, and health related quality of life and burden of illness through response to self-administered questionnaires. No investigational product will be administered to participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Acting Beta Agonist (SABA) | Drug | Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe asthma patients eligible for one or more biologic treatments for asthma | Biologic treatments for asthma will include mepolizumab (anti-Interleukin [IL] 5), omalizumab (anti-immunoglobulin E [IgE]), and reslizumab (anti-IL5). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean and median frequency of planned and unplanned asthma-related healthcare resource utilization in the prior 12 months | Day 1 | |
| Mean and median Charlson Comorbidity Index score | The Charlson Comorbidity Index is a score that is based on age and the presence of 19 comorbidities. The mean and median Charlson Comorbidity Index score will be calculated and reported |
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Inclusion Criteria:
Patients must be treated with high dose ICS PLUS at least one of the following: LABA, leukotriene modifier, theophylline, or continuous or near continuous systemic corticosteroid (i.e., maintenance systemic corticosteroid for ≥50% of the previous year).
SPECIAL CIRCUMSTANCE: If patient is on a fixed dose combination medication, then the maximum recommended dose of the ICS/LABA combination per local label is acceptable.
Exclusion Criteria:
Participants who have participated in an interventional clinical trial for asthma within the past 12 months prior to Visit 1 (NOTE: subjects participating in an observational study where an investigational product or procedure is not administered will not be subject to this exclusion criteria)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31874051 | Derived | Mullerova H, Cockle SM, Gunsoy NB, Nelsen LM, Albers FC. Clinical characteristics and burden of illness among adolescent and adult patients with severe asthma by asthma control: the IDEAL study. J Asthma. 2021 Apr;58(4):459-470. doi: 10.1080/02770903.2019.1708095. Epub 2020 Jan 9. | |
| 31251094 | Derived | Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 4, 2017 | |
| Reset | May 12, 2017 | |
| Release | Jun 6, 2017 |
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| Day 1 |
| Mean pre-bronchodilator forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean post-bronchodilator FEV1/FVC ratio | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean pre-bronchodilator FEV1 | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean post-bronchodilator FEV1 | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean pre-bronchodilator FVC | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean post-bronchodilator FVC | Spirometry assessment will be performed with mean pre- and post-bronchodilator FEV1/FVC, pre- and post-bronchodilator FEV1 and FVC, and airway reversibility | Day 1 |
| Mean and median levels of blood eosinophils | Day 1 |
| Mean and median levels of total IgE | Day 1 |
| Mean and median levels of specific IgE | Day 1 |
| Descriptive statistics for asthma Control Questionnaire (ACQ-5) | Day 1 |
| Descriptive statistics for St. George's Respiratory Questionnaire (SGRQ) | Day 1 |
| Descriptive statistics for Asthma Quality of Life Questionnaire (AQLQ-S) | Day 1 |
| Descriptive statistics for EuroQol 5D (EQ-5D-5L) | Day 1 |
| Descriptive statistics for Work Productivity and Activity Impairment Index: General Health (WPAI-GH) | Day 1 |
| Descriptive statistics for Asthma Symptom Utility Index (ASUI) | Day 1 |
| Fresno |
| California |
| 93720 |
| United States |
| GSK Investigational Site | Los Angeles | California | 90025 | United States |
| GSK Investigational Site | Newport Beach | California | 92663 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42301 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Columbia | Maryland | 21044 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | United States |
| GSK Investigational Site | Corning | New York | 14830 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28277 | United States |
| GSK Investigational Site | Shelby | North Carolina | 28150 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Coffs Harbour | New South Wales | 2450 | Australia |
| GSK Investigational Site | Sherwood Park | Alberta | T8H 0N2 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 0G1 | Canada |
| GSK Investigational Site | Burlington | Ontario | L7N 3V2 | Canada |
| GSK Investigational Site | Grimsby | Ontario | L3M1P3 | Canada |
| GSK Investigational Site | London | Ontario | N6A1V2 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5A 3V4 | Canada |
| GSK Investigational Site | St-Charles-Borromée | Ontario | J6E 2B4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1E2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5T 3A9 | Canada |
| GSK Investigational Site | Windsor | Ontario | N8X2G1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4M6 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| GSK Investigational Site | Bayonne | 64109 | France |
| GSK Investigational Site | Dijon | 21033 | France |
| GSK Investigational Site | Grenoble | 38043 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Lyon | 69317 | France |
| GSK Investigational Site | Marseille | 13331 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Nantes | 44277 | France |
| GSK Investigational Site | Paris | 75877 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Reims | 51092 | France |
| GSK Investigational Site | Rouen | 76031 | France |
| GSK Investigational Site | Strasbourg | 67091 | France |
| GSK Investigational Site | Tarbes | 65013 | France |
| GSK Investigational Site | Villefranche-sur-Saône | 69655 | France |
| GSK Investigational Site | Gauting | Bavaria | 82131 | Germany |
| GSK Investigational Site | Munich | Bavaria | 80539 | Germany |
| GSK Investigational Site | Cottbus | Brandenburg | 03050 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 22299 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04357 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23552 | Germany |
| GSK Investigational Site | Schleswig | Schleswig-Holstein | 24837 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12157 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 12203 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13086 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13597 | Germany |
| GSK Investigational Site | Birmingham | B15 2WB | United Kingdom |
| GSK Investigational Site | Birmingham | B18 7QH | United Kingdom |
| GSK Investigational Site | Cambridge | CB2 2XY | United Kingdom |
| GSK Investigational Site | Crawley | RH10 7DX | United Kingdom |
| GSK Investigational Site | Liverpool | L12 2AP | United Kingdom |
| GSK Investigational Site | London | SW17 0RE | United Kingdom |
| GSK Investigational Site | Middlesbrough | TS4 3BW | United Kingdom |
| GSK Investigational Site | Radstock, Bath | BA3 2UH | United Kingdom |
| GSK Investigational Site | Salford | M6 8HD | United Kingdom |
| GSK Investigational Site | Trowbridge | BA14 9AR | United Kingdom |
| 28622052 | Derived | Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, Cockle SM, Suruki RY. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2018 Feb;55(2):152-160. doi: 10.1080/02770903.2017.1322611. Epub 2017 Jun 16. |
| Unrelease | Yes |
| Release | Sep 21, 2017 |
| Unrelease | Yes |
| Release | Dec 19, 2017 |
| Unrelease | Yes |
| Release | Feb 1, 2018 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 4, 2017 | May 12, 2017 | |||
| Jun 6, 2017 | Yes | |||
| Sep 21, 2017 | Yes | |||
| Dec 19, 2017 | Yes | |||
| Feb 1, 2018 | Aug 15, 2018 |
| 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 |
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