RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: RELVAR 100 ELLIPTA

Study type: Observational

Funder types: Industry

Identifiers

NCT03219255

205653

Details and patient eligibility

About

This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA® (hereinafter referred to as "Relvar") in daily clinical practice in subjects with chronic obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from approximately 200 medical institutions, will be registered for this study and 332 of them will be considered for safety analysis. In the investigation, subject registration and data collection will be conducted using an Electronic Data Capture (EDC) system. Post-registration, the investigator will monitor the information regarding the safety and efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia, systemic effects caused by corticosteroids and cardiovascular events will be considered as the priority investigation matters. At the end of observation period, the investigator will enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Enrollment: 1,047 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with a diagnosis of COPD (bronchitis chronic/emphysema) and who are naive to RELVAR will be included.

Exclusion criteria

• Among subjects with concomitant asthma, subjects with experience of taking RELVAR for treatment of asthma will be excluded from the investigation.

Trial design

1,047 participants in 1 patient group

Subjects receiving RELVAR 100 ELLIPTA

Description:

Subjects with a diagnosis of COPD, for which RELVAR is indicated, who are naive to RELVAR will be included.

Treatment:

Drug: RELVAR 100 ELLIPTA