ORBE: Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
Study Details
Study Description
Brief Summary
Observational, retrospective study in adults (≥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 investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.
Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.
Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Age [Up to 32 weeks]
Age (years)
- Sex [Up to 32 weeks]
Male, Female
- Body Mass Index (BMI) [Up to 32 weeks]
Weight and height will be combined to report BMI in kg/m^2
- Smoking status [Up to 32 weeks]
Current smoker, Ex-smoker, Never smoker
- Age at onset of asthma diagnosis [Up to 32 weeks]
Age (years)
- Comorbidities [Up to 32 weeks]
Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases
- Severe exacerbations [Up to 32 weeks]
Severe exacerbations in past 12 months: number and severity
- Emergency room (ER) visits [Up to 32 weeks]
Number of ER visits
- Hospitalizations [Up to 32 weeks]
Number of hospitalizations
- Unscheduled visits [Up to 32 weeks]
Number of unscheduled visits
- ACT [Up to 32 weeks]
ACT questionnaire score
- miniAQLQ [Up to 32 weeks]
miniAQLQ questionnaire score
- Blood eosinophils [Up to 32 weeks]
Blood eosinophils count (cells/microL)
Secondary Outcome Measures
- Incidence of severe exacerbations [Up to 32 weeks]
The incidence rate for any severe exacerbations in each calendar year will be calculated as follows: the sum of any severe exacerbations in that year divided by the total duration of follow-up in the same calendar year.
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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Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
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Informed consent signed
Exclusion Criteria:
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Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
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Refuse to sign the informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | BIG PAC | Madrid | Spain |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D3250R00052