Post-marketing surveillance (PMS) on long-term use of tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) 5/5µg in patients with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) in Japan (Japanese Spiolt PMS, long term)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30567
• EU PAS number:
  EUPAS14273
• Study ID:
  30567
• Official title and acronym:
  Post-marketing surveillance (PMS) on long-term use of tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) 5/5µg in patients with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) in Japan (Japanese Spiolt PMS, long term)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with COPD in real-world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/09/2015

Actual: 18/09/2015

Study start date

Planned: 23/08/2016

Actual: 23/08/2016

Data analysis start date

Planned: 23/08/2016

Actual: 23/08/2016

Date of final study report

Planned: 30/06/2019

Actual: 11/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Study protocol

Initial protocol

Synopsis-1237-34

Regulatory

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