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 RCV NIS)

Study identification

• EU PAS number:
  EUPAS12864
• Study ID:
  13460
• 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 RCV NIS)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Croatia

  Czechia

  Hungary

  Israel

  Romania

  Russian Federation

  Slovakia

  Slovenia

  Switzerland
• Study description:
  The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto Respimat after approximately 6 weeks.The secondary objective is to evaluate the patient’s general condition (physician’s evaluation) at visit 1 (= baseline visit at the start of the study) and at visit 2 (= final visit approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto Respimat at visit 2.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned:13/05/2015

Actual:13/05/2015

Study start date

Planned:19/04/2016

Actual:11/04/2016

Date of final study report

Planned:30/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim RCV GmbH & Co KG

Regulatory

• Was the study required by a regulatory body?:
  No