Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice (OTIVACTO)

Study identification

• EU PAS number:
  EUPAS12750
• Study ID:
  29160
• Official title and acronym:
  Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice (OTIVACTO)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Luxembourg

  Netherlands

  Portugal

  Sweden
• Study description:
  Assessment of physical functioning and handling of Spiolto®
• Study status:
  Finalised

Research institutions and networks

Institutions

Cynthia de Roos-Verkleij

Multiple centres: 30 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/09/2015

Actual:01/09/2015

Study start date

Planned:01/09/2016

Actual:08/11/2016

Data analysis start date

Planned:15/05/2018

Actual:21/06/2018

Date of final study report

Planned:22/12/2018

Actual:07/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable