Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice (OTIVACTO)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Influence of treatment on patient's physical functioning
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Single group, open, non-randomised, observational

Study drug and medical condition

• Medicinal product name, other:
  Spiolto Respimat
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients with chronic obstructive pulmonary disease (COPD) requiring long-acting dual bronchodilation in routine clinical practice who were on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  1200

Study design details

• Main study objective:
  To measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks
• Outcomes:
  Changes in physical functioning based on PF-10 scores, Patients' general condition using the Physician's Global Evaluation (PGE) scalePatients' satisfaction with Spiolto Respimat using a Patient Satisfaction Survey
• Data analysis plan:
  Descriptive statistics