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

• PURI:
  https://redirect.ema.europa.eu/resource/16933
• EU PAS number:
  EUPAS16629
• Study ID:
  16933
• 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:
  Italy
• Study description:
  Reduced physical activity resulting in deconditioning and restricted physical functioning is a common constraint of patients with moderate to very severe COPD. Clinical studies investigating treatment with Spiolto® Respimat® and its single components have shown significant improvements in exercise capacity in patients with COPD.Real-world data on the effects of a fixed-dose combination (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available.)
• Study status:
  Planned

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 13/02/2017

Study start date

Planned: 20/02/2017

Data analysis start date

Planned: 27/02/2017

Date of final study report

Planned: 30/06/2018

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