Assessment of dyspnea and other symptoms as patient reported outcomes (PRO) in patients with chronic obstructive pulmonary disease (COPD), symptomatic on LABA/ICS maintenance therapy (now) treated with Spiolto® Respimat® (tiotropium/olodaterol) in comparison to open or fixed triple combination treatment in routine clinical practice (EVELUT)

Study identification

• EU PAS number:
  EUPAS29784
• Study ID:
  48046
• Official title and acronym:
  Assessment of dyspnea and other symptoms as patient reported outcomes (PRO) in patients with chronic obstructive pulmonary disease (COPD), symptomatic on LABA/ICS maintenance therapy (now) treated with Spiolto® Respimat® (tiotropium/olodaterol) in comparison to open or fixed triple combination treatment in routine clinical practice (EVELUT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  This prospective open-label observational study aims to analyze the comparative effectiveness of Spiolto® Respimat® in the new reusable inhaler vs any triple therapy in reducing dyspnea and symptom burden from each individual patient’s score difference between baseline and after approximately 12 weeks of treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Universitätsmedizin der Johannes Gutenberg

Study timelines

Date when funding contract was signed

Planned:21/11/2018

Actual:21/11/2018

Study start date

Planned:31/05/2019

Actual:14/06/2019

Data analysis start date

Actual:15/12/2021

Date of final study report

Planned:30/09/2022

Actual:19/09/2022

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