ORBE-II: Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.
Study Details
Study Description
Brief Summary
Primary Objectives:
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To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
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To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Benralizumab Patients that received at least one dose of benralizumab according to routine clinical practice |
Outcome Measures
Primary Outcome Measures
- Age [Up to 12 months (Baseline period)]
Specifically, at the time of taking the first dose of study drug
- Gender [Up to 12 months (Baseline period)]
Specifically, at the time of taking the first dose of study drug
- 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 [Baseline period]
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)
- AQLQ score [Baseline period]
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
- 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 [Baseline period]
Split by primary care and specialist (asthma related)
- Emergency room visits [Baseline period]
- Hospitalisations [Baseline period]
Number and duration
- Number of laboratory tests per patient [Baseline period]
- Number of conventional radiology procedures per patient [Baseline period]
- Number of diagnostic/therapeutic tests per patient [Baseline period]
Asthma related only
- 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 [Up to 24 months (study duration)]
Including previous biologic treatment, type of treatment and reasons for discontinuation or switching
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients (age ≥18 years)
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Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller.
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Patients with at least 12-month data available before index date (starting benralizumab treatment)
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Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
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Informed consent signed.
Exclusion Criteria:
- Patients who received benralizumab in a clinicaltrial, during the observation period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Madrid | Spain | 28041 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D3250R00079