Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain. (ORBE-II)

Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.

Primary Objectives:

1. 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
2. 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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 β2 ± additional asthma controller.
• Patients with at least 12-month data available before index date (starting benralizumab treatment)
• Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
• Informed consent signed.

Exclusion Criteria:

• Patients who received benralizumab in a clinicaltrial, during the observation period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Benralizumab; Patients that received at least one dose of benralizumab according to routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): July 16, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D3250R00079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No