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 SPAIN)

Study identification

• EU PAS number:
  EUPAS13754
• Study ID:
  32075
• 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 SPAIN)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
• Study status:
  Finalised

Research institutions and networks

Institutions

Centro de Salud Francia

Multiple centres: 120 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:02/02/2016

Actual:16/06/2016

Study start date

Planned:22/05/2017

Actual:17/05/2017

Data analysis start date

Planned:01/03/2019

Actual:13/03/2019

Date of final study report

Planned:27/09/2019

Actual:04/09/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Spain

Regulatory

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