FASENRA SCEI for Long-term Use

Completed

• Conditions: Asthma

• Registration Number: NCT03588546
• Lead Sponsor: AstraZeneca

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).

Study Timeline

• Study First Submitted: 2018-05-25
• Study Start: 2018-05-31
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-17
• Status Verified: 2024-09
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidences of adverse drug reactions (ADRs) [all ADRS, unexpected ADRs and key investigational safety specification (serious infection)]	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamaguchi, Japan