Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan (212606)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48198
• EU PAS number:
  EUPAS44882
• Study ID:
  48198
• Official title and acronym:
  Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan (212606)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study status:
  Ongoing

Research institution and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned: 31/03/2022

Study start date

Planned: 31/01/2022

Actual: 20/04/2022

Date of final study report

Planned: 17/07/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Study protocol

Initial protocol

gsk-212606-protocol-orig-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only