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The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SEA+NP Patients on FASENRA (benralizumab) | SEA+NP Patients on FASENRA (benralizumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FASENRA(benralizumab) | Other | This is a retrospective, observational study with secondary data collection utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization. | To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization. | At or up to 12 months prior to first benralizumab dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Total NPS | To describe the distribution (mean, median, range) of NPS (nasal polyp score) before and after initiation of benralizumab among SEA (severe eosinophilic asthma) +NP (nasal polyps) patient. NPS is the sum of the left and the right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps. | Up to 12 months prior to and up to 12 months from first benralizumab dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma medications | To describe asthma medications. | Up to 12 months from first benralizumab dose. |
| NP medications | To describe NP medications. |
Inclusion Criteria:
Exclusion Criteria:
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The study population is SEA + NP patients on benralizumab.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Centennial | Colorado | 80112 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38595692 | Derived | Le TT, Emmanuel B, Katial R, Tran TN, Kwiatek JJ, Cohen DS, Daniel SR, Cao Y, Shih VH, Melcon MG, Devouassoux G, Pelaia G; RANS Study Investigators. Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study. J Asthma Allergy. 2024 Apr 5;17:313-324. doi: 10.2147/JAA.S437190. eCollection 2024. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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|
| SNOT-22 total score | To describe the distribution (mean, median, range) of NP patient reported HRQoL total score (SNOT-22[Sino-nasal Outcome Test-22]) before and after initiation of benralizumab among EA+NP patients. SNOT-22 measures physical problems, functional limitations, and emotional consequences of sino-nasal conditions. SNOT-22 total score is calculated as the sum of all 22 responses and range from 0 to 110 (higher scores indicate poorer HRQoL). | Up to 12 months prior to and up to 12 months from first benralizumab dose. |
| Overall SCS use. SCS use for asthma only. SCS use for NP only | To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients | Up to 12 months from first benralizumab dose. |
| Asthma Clinical outcomes. | To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns. | Up to 12 months from first benralizumab dose. |
| NP surgery type and/or procedure | Proportion of patients with different type of surgery and/or procedure | Up to 12 months from first benralizumab dose. |
| Repeated or revision surgery for NP | Proportion of patients with repeated or revision surgery | Up to 12 months from first benralizumab dose. |
| Time to NP surgery | Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery | Up to 12 months from first benralizumab dose. |
| NP surgery complications | Proportion of patients with minor and major surgical complication. | Up to 12 months from first benralizumab dose. |
| Up to 12 months from first benralizumab dose. |
| All-cause healthcare resource utilization | To describe all-cause healthcare resources utilization. | Up to 12 months from first benralizumab dose. |
| Asthma-related healthcare resources utilization | To describe asthma-related healthcare resources utilization. | Up to 12 months from first benralizumab dose. |
| NPS by subgroups | To describe the distribution (mean, median) of NPS among subgroups of patients with different characteristics: demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations). NPS is the the sum of left and right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps. | Up to 12 months prior to and up to 12 months from first benzelizumab dose. |
| SNOT-22 total score by subgroups | To describe the distribution (mean, median) of SNOT-22 total scores among subgroups of patients with different characteristics : demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations). SNOT-22 measures physical problems, functional limitations, and emotional consequences of sino-nasal conditions. SNOT-22 total score is calculated as the sum of all 22 responses and range from 0 to 110 (higher scores indicate poorer HRQoL). | Up to 12 months prior to and up to 12 months from first benralizumab dose. |
| Denver |
| Colorado |
| 80206 |
| United States |
| Research Site | Glendale | New York | 11385 | United States |
| Research Site | New York | New York | 10029 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | Philadelphia | Pennsylvania | 19107 | United States |
| Research Site | Norfolk | Virginia | 23507 | United States |
| Research Site | Lyon | 69317 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Montpellier | 34090 | France |
| Research Site | Nantes | France |
| Research Site | Strasbourg | France |
| Research Site | Lübeck | Germany |
| Research Site | Wiesbaden | 65183 | Germany |
| Research Site | Catania | 95123 | Italy |
| Research Site | Catanzaro | 88100 | Italy |
| Research Site | Florence | 50134 | Italy |
| Research Site | Milan | 20162 | Italy |
| Research Site | Modena | 41124 | Italy |
| Research Site | Monserrato | 09042 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Orbassano | Italy |
| Research Site | Ragusa | 97100 | Italy |
| Research Site | Rome | 00161 | Italy |
| Research Site | Rome | Italy |
| Research Site | Salerno | 84131 | Italy |
| Research Site | Varese | 21100 | Italy |
| Research Site | Chuo-ku, Niigata-Shi | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Moriguchi-Shi | Japan |
| Research Site | Nagaoka-Shi | Japan |
| Research Site | Shinagawa-ku | Japan |
| Research Site | Yonago-Shi | Japan |
| Research Site | A Coruña | 15006 | Spain |
| Research Site | Alcorcón | 28922 | Spain |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Cadiz | 11407 | Spain |
| Research Site | Madrid | 28041 | Spain |
| Research Site | Madrid | Spain |
| Research Site | Salamanca | 37007 | Spain |
| Research Site | Seville | 41071 | Spain |
| Research Site | Seville | 46017 | Spain |
| Research Site | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D011657 | Pulmonary Eosinophilia |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017681 | Hypereosinophilic Syndrome |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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