Real world evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)

Study identifier:D3250R00101

ClinicalTrials.gov identifier:NCT05271526

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A multicenter, single arm, non-interventional, observational, prospective study to assess demographic characteristics, burden of disease and short-term patient reported outcomes on symptom relief in severe eosinophilic asthma patients aged older than 18 qualifying for treatment with benralizumab in Russia

Medical condition

Severe Eosinophilic Asthma

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Observational

Age

n/a - n/a

Date

Study Start Date: 16 May 2022

Primary Completion Date: 13 Nov 2023

Study Completion Date: 13 Nov 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Dec 2023 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Russian label and in line with reimbursement condition must meet all the following criteria:
- Male or female patients older than 18 years with physician’s confirmed diagnosis of severe, uncontrolled asthma.
- Asthma requiring high-dose ICS plus LABA as maintenance treatment.
- Minimum of 2 exacerbations in the last 12 months. Or 1 exacerbation in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day)
- Documented peripheral blood eosinophil count ≥ 300 cells/μL or ≥150 cells/μL blood in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day).
- Provision of signed written 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 (SGRQ, ACQ-5, PGIC and PGIS).

Exclusion Criteria

Patients who have previously received benralizumab prior to the start of the study.
- Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
- Concomitant treatment with any other biologic for any indication or previous treatment with biology. Acceptable wash-out periods for other asthma biologics: ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
- 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 ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
- 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.

No locations available

Arms	Assigned Interventions

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]