Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

Severe Eosinophilic Asthma Clinical Trial

— ORBE  

Official title:

Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126499
• Other study ID #: D3250R00052
• Status: Completed
• Start date: January 13, 2020
• Est. completion date: May 8, 2020

Study information

• Verified date: June 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 8, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Adult patients (age =18 years)

• Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist ß2 ± additional asthma controller

• Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)

• Informed consent signed

Exclusion Criteria:

• Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program

• Refuse to sign the informed consent

Related Conditions & MeSH terms

• Pulmonary Eosinophilia
• Severe Eosinophilic Asthma

Locations

Country	Name	City	State
Spain	BIG PAC	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Age (years)	Up to 32 weeks
Primary	Sex	Male, Female	Up to 32 weeks
Primary	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2	Up to 32 weeks
Primary	Smoking status	Current smoker, Ex-smoker, Never smoker	Up to 32 weeks
Primary	Age at onset of asthma diagnosis	Age (years)	Up to 32 weeks
Primary	Comorbidities	Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases	Up to 32 weeks
Primary	Severe exacerbations	Severe exacerbations in past 12 months: number and severity	Up to 32 weeks
Primary	Emergency room (ER) visits	Number of ER visits	Up to 32 weeks
Primary	Hospitalizations	Number of hospitalizations	Up to 32 weeks
Primary	Unscheduled visits	Number of unscheduled visits	Up to 32 weeks
Primary	ACT	ACT questionnaire score	Up to 32 weeks
Primary	miniAQLQ	miniAQLQ questionnaire score	Up to 32 weeks
Primary	Blood eosinophils	Blood eosinophils count (cells/microL)	Up to 32 weeks
Secondary	Incidence of severe exacerbations	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.	Up to 32 weeks

External Links

•   CSR Synopsis