Changes in functional status in patients with COPD during therapy with Spiolto® Respimat® (Ellacto study)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  QoL evaluation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM BROMIDE MONOHYDRATE

  OLODATEROL HYDROCHLORIDE
• 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:
  1363

Study design details

• Main study objective:
  The primary objective of this NIS is to measure changes in health and functional status using the CCQ score, in COPD patients on treatment with Spiolto® Respimat® after approximately 6 weeks.
• Outcomes:
  The secondary objectives are to evaluate the absolute change in the CCQ and CCQ-4 between Visit 1 (baseline visit at the start of the study) and Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), the patient’s general condition (physician’s evaluation) at Visit 1 and at Visit 2, as well as patient satisfaction
• Data analysis plan:
  Primary endpoint: proportion of patients achieving “therapeutic success” (= 0.4 point decrease in the CCQ score between baseline and week 6) R17-0254.0.4 points is the well accepted MCID R17-0256 Secondary endpoints:Absolute change in the CCQ Absolute change in CCQ-4.Patient´s general condition: 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) (abbreviated PASAPQ Part 1).Patient preference HH (HandiHaler) vs RMT (Respimat) Inhaler devices – only for those patients that used Spiriva HH previous to the study (PASAPQ Part 2).Treatment continuation of Spiolto® Respimat® after the study.