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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Spiolto Respimat
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1300

Study design details

• Main study objective:
  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.
• Outcomes:
  The primary outcome is to measure the proportion of patients achieving the “therapeutic success” defined as a ≥ 0.4 point of increase in the Clinical COPD Questionnaire (CCQ) score (specifically functional status subdomain of CCQ) between baseline and week 6. - Absolute change in the CCQ- Absolute change in CCQ-4.- Physician´s Global Evaluation (PGE) score at baseline and end of study.- Patient satisfaction with (tiotropium and olodaterol) Respimat® at end of study using a seven-point ordinal scale (ranging from very dissatisfied to very satisfied) of the PASAPQ.- Patient preference HH vs RMT (PASAPQ)
• Data analysis plan:
  All patients who have received at least one dose of Spiolto® Respimat® will be included in the analyses, this is the treated set. All analyses will be performed on the treated set (as treated analysis). If patients have missing values for an outcome, those patients will be excluded for that outcome’s analysis. For example, if a patient is missing the CCQ score at Visit 1 and/or Visit 2, that patient will be excluded from the analyses for the primary endpoint of therapeutic success and the secondary endpoint of change in CCQ from Visit 1 to Visit 2.The statistical characteristics presented in the end-of-text tables will be N / mean / SD / min / median / max for continuous variables. Tabulations of relative and absolute frequencies will be presented for categorical variables. Incidence rates and 95% CI will be given when appropriate.