Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
None listed
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment.Timepoint: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment. - Percentage of patients with a total score improvement of = 0.5 points (minimal clinically important difference [MCID]) in ACQ-6 at 1, 2, 3, 4, 8, 24, and 56 weeks of receiving benralizumab compared to baseline - Percentage of patients with well-controlled asthma (ACQ-6 = 0.75), partly controlled asthma (ACQ-6 between 0.75 and 1.5), and uncontrolled asthma (ACQ-6 = 1.5) at baseline and at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment The patient global impression of change (PGI-C) response at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment - The patient global impression of severity (PGI-S) response at 0, 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Timepoint: 56 weeks | — |
Countries
Argentina, Brazil, Colombia, India, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates
Contacts
Public ContactAmit Kumar
AstraZeneca Pharma India Ltd
Outcome results
None listed