Specific Use-result Surveillance of Spiriva Respimat in asthmatics (patients with mild to moderate persistent asthma) (Specific Use-result Surveillance in asthmatics)

Study identification

• EU PAS number:
  EUPAS19173
• Study ID:
  31192
• Official title and acronym:
  Specific Use-result Surveillance of Spiriva Respimat in asthmatics (patients with mild to moderate 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 mild to moderate 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:07/05/2014

Actual:07/05/2014

Study start date

Planned:01/07/2017

Actual:25/07/2017

Data analysis start date

Planned:31/01/2019

Actual:07/12/2018

Date of final study report

Planned:31/07/2019

Actual:25/04/2019

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