A regulatory required non interventional study to monitor the safety and effectiveness of once daily treatment of orally inhaled Vahelva Respimat (Tiotropium + Olodaterol fixed dose combination 2.5µg/2.5µg per puff (2 puffs comprise one medicinal dose)) for Korean patients with COPD (Chronic Obstructive Pulmonary Disease) (Vahelva Respimat regulatory Post-marketing Surveil)

Study identification

• EU PAS number:
  EUPAS14956
• Study ID:
  48428
• Official title and acronym:
  A regulatory required non interventional study to monitor the safety and effectiveness of once daily treatment of orally inhaled Vahelva Respimat (Tiotropium + Olodaterol fixed dose combination 2.5µg/2.5µg per puff (2 puffs comprise one medicinal dose)) for Korean patients with COPD (Chronic Obstructive Pulmonary Disease) (Vahelva Respimat regulatory Post-marketing Surveil)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study description:
  To monitor the safety profile and effectiveness of Vahelva Respimat in Korean patients with COPD in a routine clinical practice setting
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/09/2016

Actual: 14/12/2016

Study start date

Planned: 30/09/2016

Actual: 19/12/2016

Date of final study report

Planned: 30/06/2022

Actual: 30/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

1237.6