Real World Study With Benralizumab in Severe Asthma in Switzerland (BEEPS)

Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland

BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.

Study Overview

• Status: Completed
• Conditions: Severe Eosinophilic Asthma

Detailed Description

The aim and objective of this single arm, prospective observational study is to describe patient reported outcomes (PRO) in severe eosinophilic asthma patients who are treated with benralizumab according to the label granted in Switzerland. The PRO measures consist of the weekly Asthma Control Questionnaire (ACQ-5) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S) collected at each visit (0, 1, 2, 4, 8, 16, 56 weeks). In addition the patient fills out twice daily the patient electronic asthma diary (eDiary) capturing daily symptoms and symptom free days together with a PEF (Peak Expiratory Flow) measurement. Persistance with eDiary and PEF will be assessed after 56 weeks. The percentage of patients successfully reducing their OCS dose will be evaluated after 16 weeks of treatment with benralizumab and if OCS reduction is persistent until week 56. Furthermore, the proportion of patients with an ACQ-5 score improvement of ≥ 0.5 after 8 weeks of treatment with benralizumab will be determined. In addition, the study will assess changes in FEV1 and FVC after 8, 16 and 56 weeks of treatment with benralizumab and describe retrospectively asthma disease history, past treatment status and current medication at baseline.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Switzerland
  • Aathal, Switzerland, 8607
    • Research Site
  • Basel, Switzerland, 4031
    • Research Site
  • Bern, Switzerland, 3010
    • Research Site
  • Chur, Switzerland, 7000
    • Research Site
  • Geneva, Switzerland, 1211
    • Research Site
  • Liestal, Switzerland, 4410
    • Research Site
  • Luzern, Switzerland, 6000
    • Research Site
  • Sion, Switzerland, 1950
    • Research Site
  • Wetzikon, Switzerland, 8620
    • Research Site
  • Zurich, Switzerland, 8032
    • Research Site
  • Zurich, Switzerland, 8006
    • Research Site
  • Zurich, Switzerland, 8044
    • Research Site

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

The study will recruit 77 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria. Approximately 15-20 specialist centres across Switzerland will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab and have a good oversight on the severe asthma population, as in some settings the patients are referred for longer term stationary care to achieve asthma control.

Description

Inclusion Criteria:

Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:

1. Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
2. Asthma requiring high-dose ICS plus LABA as maintenance treatment.
3. Minimum of 2 exacerbations in the last 12 months.
4. Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
5. Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
6. Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol (ACQ-5, PGI-C and PGI-S).

Exclusion Criteria:

Subjects meeting any of the following criteria will not be eligible to participate in the study:

1. Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.

2. Currently enrolled in an interventional clinical study in parallel, except:

   • Patients being in parallel documented in a national asthma registry.
   • Patients having completed any other clinical trial including those with biologic treatment.
3. An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab	The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.	In patients who take continuous oral corticosteroids (OCS) the fraction of patients who reduced the dosage of OCS is assessed. Daily oral OCS dosage in this patient group usually ranges from 2,5 to 40mg.	16, 56 weeks
Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.	The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.	1, 2, 4, 16, 56 weeks
Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.	The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.	1,2,4,8,16,56 weeks
Change from baseline in PGI-C in asthma.	The Patient Global Impression of Change (PGI-C) rates the patients general impression of his asthma health status since study start on a scale from 1 to 7. 1 meaning much better, 4 equal and 7 much worse.	1, 2, 4, 8, 16, 56 weeks
Change from baseline in PGI-S in asthma	The Patient Global Impression of Severity (PGI-S) rates the current asthma status on a scale from 1 to 6. 1 meaning no symptoms and 6 meaning very heavy symptoms.	1, 2, 4, 8, 16, 56 weeks
Asthma disease history	The time and age of first asthma diagnosis, the presence of allergic cofactors and the history of exacerbations in the last 12 month since study start will be recorded.	Baseline
Past treatment status	Prescribed medication for Astma in the last 12 month before study enrollment will be recorded. Special emphasis will be put on inhallation therapy and OCS use and any changes. Any previous biological therapy will be recorded as well.	Baseline
Patient demographics	Age (Years), sex (m/f), weight (kg) and height (cm) will be recorded	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in PEF under treatment with benralizumab	PEF=Peak Expiratory Flow; Measured in litres (l)	1, 2, 4, 8, 16, 56 weeks
Outcome deterioration of asthma status (CompEx) with an electronic diary (app on smartphone) filled out by the patient.	The morning diary comprises four questions, the evening diary comprises three questions assessing the current asthma status. The scores will be summarised to defie a Compex event which is defined as 2 of the following criteria for ≥ 2 consecutive days: • ≥15% decrease from baseline in morning or evening PEF And at least one of the following: ≥1.5 puffs increase from baseline in rescue medication morning or evening; ≥1 score increase from baseline, or the absolute maximal asthma symptom score in the morning or evening. Or one of the criteria above together with all diary variable showing a slope of worsening over at least a 5-day period.	Twice Daily throughout the study duration (16 weeks)
Pre- and postbronchodilator changes in FEV1 under treatment with benralizumab.	Forced Expiratory Volume in One Second (FEV1) is assessed by standard spirometry (measured in litres).	0, 8, 16, 56 weeks
Pre- and postbronchodilator changes in FVC under treatment with benralizumab	Forced vital capacity will be assessed by standard routine spirometry (measured in liters).	0, 8, 16, 56 weeks
Change in OCS medication (median change in mg)	Median OCS dose reduction	4, 8, 16, 56 weeks
Percentage of patients with OCS reduction	Proportion of patients with a ≥25%, ≥50%, ≥75% and 100% OCS dose reduction Percentage of patients on OCS who were able to reduce their OCS dose	4, 8, 16, 56 weeks
Change of nasal polyposis relevant health status (taste and smell)	For patients with nasal polyposis at baseline any improvement on taste/smell will be recorded categorically (yes/no)	1, 2, 4, 8, 16, 56 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Thomas Rothe, Dr. med., Kantonsspital Graubunden

Publications and helpful links

Helpful Links

• D3250R00048_BEEPS_CSR_Synopsis_022024_Redacted.pdf

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Pulmonary Eosinophilia
• Other Study ID Numbers: D3250R00048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No