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

NCT04648839 | Completed

• 1 other identifier: D3250R00079
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 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. 2.To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (26)

• 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)

Study Arms (1)

Benralizumab

Patients that received at least one dose of benralizumab according to routine clinical practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Madrid, 28041, Spain

Location

Related Publications (1)

• Padilla-Galo A, Moya Carmona I, Ausin P, Carazo Fernandez L, Garcia-Moguel I, Velasco-Garrido JL, Andujar-Espinosa R, Casas-Maldonado F, Martinez-Moragon E, Martinez Rivera C, Vera Solsona E, Sanchez-Toril Lopez F, Trisan Alonso A, Blanco Aparicio M, Valverde-Monge M, Valencia Azcona B, Palop Cervera M, Nuevo J, Sanchez Tena J, Resler G, Luzon E, Levy Naon A. Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study. Respir Res. 2023 Sep 28;24(1):235. doi: 10.1186/s12931-023-02539-7.

  PMID: 37770889 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: December 2, 2020
• Study Start: February 16, 2021
• Primary Completion: July 16, 2021
• Study Completion: July 16, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

ES (1)