Long Term Special Drug Use Investigation of Mepolizumab

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Asthma

Treatments: Drug: NUCALA Injection

Study type: Observational

Funder types: Industry

Identifiers

NCT03028480

204524

Details and patient eligibility

About

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

Enrollment: 1,061 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• No exclusion criteria

Trial design

1,061 participants in 1 patient group

Subjects with Bronchial asthma

Description:

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

Treatment:

Drug: NUCALA Injection