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 (SPIRIT)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29782
• EU PAS number:
  EUPAS12709
• Study ID:
  29782
• 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 (SPIRIT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• 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. A 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 at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 650 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 31/12/2015

Actual: 31/12/2015

Study start date

Planned: 29/02/2016

Actual: 11/02/2016

Date of final study report

Planned: 16/09/2017

Actual: 06/11/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Pharma GmbH&Co.KG

Regulatory

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