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Primary Objectives:
This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab | Patients that received at least one dose of benralizumab according to routine clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | Specifically, at the time of taking the first dose of study drug | Up to 12 months (Baseline period) |
| Gender | Specifically, at the time of taking the first dose of study drug | Up to 12 months (Baseline period) |
| Smoking Habits | Up to 12 months (Baseline period) | |
| Age at athma diagnosis | Up to 12 months (Baseline period) | |
| Blood eosinophils count | Baseline period | |
| Total IgE | Baseline period | |
| Number of patients with positive Prick test | Baseline period | |
| FeNo | Baseline period | |
| Lung function (FEV1 and FVC) | Baseline period | |
| ACT (or ACQ) score | Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control. Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled) |
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Inclusion Criteria:
Exclusion Criteria:
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The target population will be all patients with severe eosinophilic asthma (those requiring stable treatment with high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller), who received at least one dose of benralizumab according to routine clinical practice, after marketing approval on January 1st, 2019. The targeted patients need to have available medical record of 12 months prior to index date.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37770889 | Derived | Padilla-Galo A, Moya Carmona I, Ausin P, Carazo Fernandez L, Garcia-Moguel I, Velasco-Garrido JL, Andujar-Espinosa R, Casas-Maldonado F, Martinez-Moragon E, Martinez Rivera C, Vera Solsona E, Sanchez-Toril Lopez F, Trisan Alonso A, Blanco Aparicio M, Valverde-Monge M, Valencia Azcona B, Palop Cervera M, Nuevo J, Sanchez Tena J, Resler G, Luzon E, Levy Naon A. Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study. Respir Res. 2023 Sep 28;24(1):235. doi: 10.1186/s12931-023-02539-7. |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline period |
| AQLQ score | Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is | Baseline period |
| Severe asthma exacerbations | In the previous 12 months |
| Key comorbidities | Baseline period |
| OCS-related comorbidities | Baseline period |
| Concomitant asthma medications | Baseline period |
| Physician office visits | Split by primary care and specialist (asthma related) | Baseline period |
| Emergency room visits | Baseline period |
| Hospitalisations | Number and duration | Baseline period |
| Number of laboratory tests per patient | Baseline period |
| Number of conventional radiology procedures per patient | Baseline period |
| Number of diagnostic/therapeutic tests per patient | Asthma related only | Baseline period |
| Number of spirometries per patient | Baseline period |
| Number of allergy tests per patient | Baseline period |
| Number of computed axial tomographies per patient | Baseline period |
| Number of magnetic resonance imaging procedures per patient | Baseline period |
| Asthma treatment | Including previous biologic treatment, type of treatment and reasons for discontinuation or switching | Up to 24 months (study duration) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |