Real World Study With Benralizumab in Severe Asthma in Switzerland

NCT03907137 | Completed

• 1 other identifier: D3250R00048
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Severe Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.

  16, 56 weeks

• Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.

  1, 2, 4, 16, 56 weeks

• Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.

  1,2,4,8,16,56 weeks

• Change from baseline in PGI-C in asthma.

  1, 2, 4, 8, 16, 56 weeks

• Change from baseline in PGI-S in asthma

  1, 2, 4, 8, 16, 56 weeks

Other Outcomes (7)

• Changes in PEF under treatment with benralizumab

  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.

  Twice Daily throughout the study duration (16 weeks)

• Pre- and postbronchodilator changes in FEV1 under treatment with benralizumab.

  0, 8, 16, 56 weeks

Eligibility Criteria

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

You may qualify if:

• Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:
• Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
• Asthma requiring high-dose ICS plus LABA as maintenance treatment.
• Minimum of 2 exacerbations in the last 12 months.
• Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
• 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.
• 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).

You may not qualify if:

• Subjects meeting any of the following criteria will not be eligible to participate in the study:
• Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Aathal, 8607, Switzerland

Location

Research Site

Basel, 4031, Switzerland

Location

Research Site

Bern, 3010, Switzerland

Location

Research Site

Chur, 7000, Switzerland

Location

Research Site

Geneva, 1211, Switzerland

Location

Research Site

Liestal, 4410, Switzerland

Location

Research Site

Lucerne, 6000, Switzerland

Location

Research Site

Sion, 1950, Switzerland

Location

Research Site

Wetzikon, 8620, Switzerland

Location

Research Site

Zurich, 8006, Switzerland

Location

Research Site

Zurich, 8032, Switzerland

Location

Research Site

Zurich, 8044, Switzerland

Location

Related Links

• D3250R00048\_BEEPS\_CSR\_Synopsis\_022024\_Redacted.pdf

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thomas Rothe, Dr. med.

  Kantonsspital Graubünden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: April 8, 2019
• Study Start: January 21, 2019
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (12)