Long Term Special Drug Use Investigation of Mepolizumab

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1061 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-11

Study Completion Date

2023-11-22

Brief Summary

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This study is a special drug use investigation program of NUCALA (a brand name for Mepolizumab) administered subcutaneously (SC). In this study the information regarding the safety and effectiveness of long term use of NUCALA after subcutaneous injection will be collected from Asthma subjects in daily clinical practice. The observation period per subject will be 52 weeks from the initiation of NUCALA treatment with follow-up investigation for 2 years after the observation period. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies

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Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with Bronchial asthma

Subjects with a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications will be enrolled

NUCALA Injection

Intervention Type DRUG

Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Interventions

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NUCALA Injection

Single dose of NUCALA SC will be administered. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects receiving NUCALA for the first time for treatment of bronchial asthma (a refractory asthma whose symptoms are inadequately controlled despite receiving standard asthma medications)

Eligible Sex

ALL

Accepts Healthy Volunteers

No