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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Evaluation of quality of life 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®)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  The primary objective of this non-interventional study (NIS) 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®).
• Outcomes:
  Mean change in patient’s quality of life (QoL) according to the total CAT score within three-months after the switch from Spiriva® Handihaler® to Spiolto® Respimat® according to the daily clinical practice. 1.Change in the proportion of patients with CAT ≥10 (representing impaired health status) within three months after the switch 2.Mean change from baseline in the total EQ VAS within three- months after the switch 3.Proportion of patients that change (improve/worsen) each of the 5 dimensions of the EQ-5D-5L within three-months after the switch
• Data analysis plan:
  For the primary outcome, mean and 95% confidence interval will be presented. Primary and secondary outcome variables will be summarized and compared between the baseline visit and the 3-months study visit after the switch to tiotropium bromide plus olodaterol (Spiolto® Respimat®). Baseline data analysis will be carried out. Comorbidities, demographic information and clinical characteristics will be described for the overall population. All categorical variables will be summarized in frequency and percentage. For the primary analysis, no treatment of missing data is planned except the imputation using the last-observation carried forward LOCF method if any post-baseline value is available in patients who discontinued before three months and for whom the value will be set as the last available measure. Sensitivity analysis will be considered using multiple imputation if more than 25% of missing values exist for a specific variable.