Specific Use-result Surveillance of Spiriva respimat in asthmatics (patients with severe persistent asthma) (Specific Use-result Surveillance in asthmatics)

Study identification

• EU PAS number:
  EUPAS9802
• Study ID:
  24759
• Official title and acronym:
  Specific Use-result Surveillance of Spiriva respimat in asthmatics (patients with severe persistent asthma) (Specific Use-result Surveillance in asthmatics)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/06/2014

Actual: 01/06/2014

Study start date

Planned: 01/06/2015

Actual: 01/06/2015

Data analysis start date

Planned: 01/06/2015

Actual: 01/06/2015

Date of final study report

Planned: 01/07/2018

Actual: 06/06/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.,

Regulatory

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