TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)
- Conditions
- Bronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)
- Registration Number
- NCT05729711
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
1. Development of related AEs
2. Contributing factors possibly having an impact on the safety and effectiveness
3. Development of unexpected related AEs
- Detailed Description
The purpose of the investigation is to confirm the followings under the post-marketing actual long-term use of Tezspire.
1. Development of related AEs
2. Contributing factors possibly having an impact on the safety and effectiveness
3. Development of unexpected related AEs
This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Act on Securing Quality, Effectiveness and Safety of Products Including Pharmaceuticals and Medical Devices.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy)
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of ADRs 156 weeks the incidence of ADRs related to Tezspire Safety Specifications: Serious hypersensitivity, infection, malignancy, cardiac disorders
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan