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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPIOLTO RESPIMAT
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  1300 patients with chronic obstructive pulmonary disease (COPD) in whom combination treatment with ; long-acting bronchodilators is indicated in accordance with the guidelines are to be observed by approx. ; 100 pulmonologists in the setting of private practice.
• 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

• Study design:
  This is a self-controlled non interventional study enrolling consented COPD patients who will be treated ; with Spiolto® Respimat® according to approved SmPC. The Patients will be enrolled consecutively and ; will be followed over an observational period of approx. 6 weeks.
• 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.
• Setting:
  It is planned that data of approximately 1300 patients from approximately 102 sites (around 100 ; pulmonologists in private practice and 2 hospital sites) throughout Greece will be collected. Each ; investigator (site) will include 10-15 consecutive patients for whom he/she decided for a treatment with ; Spiolto ® Respimat®; A log of all patients included into the study (i.e. having given informed consent) will be maintained in ; the ISF at the investigational site irrespective of whether they have been treated or not.
• 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.