Changes in functional status in patients with Chronic Obstructive Pulmonary Disease (COPD) during therapy with Spiolto® Respimat® (ELLACTO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/21423
• EU PAS number:
  EUPAS21422
• Study ID:
  21423
• Official title and acronym:
  Changes in functional status in patients with Chronic Obstructive Pulmonary Disease (COPD) during therapy with Spiolto® Respimat® (ELLACTO)
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  The aim of the NIS is to measure changes in functional statusserving as a surrogate for physical activity and exercise capacityin COPD patients receiving treatment with Spiolto ® Respimat®,at least for 6 weeks, embedded in a real life practice setting.A secondary objective is to evaluate the patient’s generalcondition (physician’s evaluation) from Visit 1 (baseline visitat the start of the study) to Visit 2 (final visit at the end of thestudy, approx. 6 weeks after Visit 1), as well as patientsatisfaction with Spiolto® Respimat® at Visit 2.
• Study status:
  Planned

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 01/11/2017

Study start date

Planned: 01/02/2018

Date of final study report

Planned: 29/03/2019

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