Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.

Severe Asthma Clinical Trial

— ORBE-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648839
• Other study ID #: D3250R00079
• Status: Completed
• Start date: February 16, 2021
• Est. completion date: July 16, 2021

Study information

• Verified date: August 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years 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.

• 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.

Related Conditions & MeSH terms

• Severe Asthma

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	Specifically, at the time of taking the first dose of study drug	Up to 12 months (Baseline period)
Primary	Gender	Specifically, at the time of taking the first dose of study drug	Up to 12 months (Baseline period)
Primary	Smoking Habits		Up to 12 months (Baseline period)
Primary	Age at athma diagnosis		Up to 12 months (Baseline period)
Primary	Blood eosinophils count		Baseline period
Primary	Total IgE		Baseline period
Primary	Number of patients with positive Prick test		Baseline period
Primary	FeNo		Baseline period
Primary	Lung function (FEV1 and FVC)		Baseline period
Primary	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
Primary	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
Primary	Severe asthma exacerbations		In the previous 12 months
Primary	Key comorbidities		Baseline period
Primary	OCS-related comorbidities		Baseline period
Primary	Concomitant asthma medications		Baseline period
Primary	Physician office visits	Split by primary care and specialist (asthma related)	Baseline period
Primary	Emergency room visits		Baseline period
Primary	Hospitalisations	Number and duration	Baseline period
Primary	Number of laboratory tests per patient		Baseline period
Primary	Number of conventional radiology procedures per patient		Baseline period
Primary	Number of diagnostic/therapeutic tests per patient	Asthma related only	Baseline period
Primary	Number of spirometries per patient		Baseline period
Primary	Number of allergy tests per patient		Baseline period
Primary	Number of computed axial tomographies per patient		Baseline period
Primary	Number of magnetic resonance imaging procedures per patient		Baseline period
Primary	Asthma treatment	Including previous biologic treatment, type of treatment and reasons for discontinuation or switching	Up to 24 months (study duration)

External Links

•   CSR Synopsis