iOUTRUN: Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

Not Applicable

Conditions: Health Condition 1: J455- Severe persistent asthma

Registration Number: CTRI/2023/03/051159

Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Male or female patients aged 18 years or older with a physician’s confirmed diagnosis of severe eosinophilic, uncontrolled asthma.

2. Severe uncontrolled eosinophilic asthma requiring high-dose inhaled corticosteroid plus long-acting ß adrenoceptor agonist as maintenance treatment.

3. Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.

4. Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.

5. Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.

Exclusion Criteria

1. Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).

2. Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry

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.

4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: =30 days from the last dose of the previous biologic.

5. Women who are currently pregnant, breastfeeding, or lactating