Asthma
Conditions
Keywords
Fasenra Benralizumab Bronchial asthma
Brief summary
The purpose of the investigation is to confirm the safety and efficacy under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe.
Detailed description
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of FASENRA Subcutaneous Injection 30 mg Syringe. 1. Detection of unexpected Adverse Drug Reactions 2. To grasp development of Adverse Drug Reactions 3. To grasp contributing factors possibly having an impact on the safety and efficacy 4. Development of key investigational safety specification (serious infection).
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-The evaluable patients treated with Fasenra for the first time due to Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy).
Exclusion criteria
-No past history of hypersensitivity to the components of Fasenra.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)] | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change scores from baseline in Asthma Control Questionnaire (ACQ) with exploring a factor to affect them by patient's background and treatment condition | 1 year |
Countries
Japan
Outcome results
None listed