Quality of life and preference of COPD patients after Switching from Tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with Tiotropium bromide plus Olodaterol (Spiolto® Respimat®) under real life conditions in Greece (ELLACTO II study)

Study identification

• EU PAS number:
  EUPAS38426
• Study ID:
  44280
• Official title and acronym:
  Quality of life and preference of COPD patients after Switching from Tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with Tiotropium bromide plus Olodaterol (Spiolto® Respimat®) under real life conditions in Greece (ELLACTO II study)
• DARWIN EU® study:
  No
• Study countries:
  Greece
• Study description:
  Non-interventional 3-months prospective, two visits, single-cohort, multicenter, nationwide study in patients with stable COPD under maintenance therapy with tiotropium monotherapy (Spiriva® Handihaler®) who, according to their treating physician, have recently required a switch (within one week) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®) in the Greek private and public sector pulmonary offices and clinics. The primary objective is to evaluate changes within 3 months in quality of life according to health status evaluated with the COPD Assessment Test (CAT) in COPD patients who have recently switched (within one week) from tiotropium monotherapy (Spiriva® Handihaler®) to dual therapy with tiotropium bromide plus olodaterol (Spiolto® Respimat®).
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual:05/03/2019

Study start date

Planned:15/03/2021

Actual:18/02/2021

Date of final study report

Planned:15/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

BOEHRINGER INGELHEIM ELLAS SA

Regulatory

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