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 SPAIN)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Open-label observational study

Study drug and medical condition

• 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:
  COPD patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks.; Inclusion criteria:; 1. Written informed consent prior to participation; 2. Female and male patients ≥ 40 years of age; 3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation
• 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:
  1000

Study design details

• Main study objective:
  The objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks.
• Outcomes:
  Therapeutic success at visit 2 (10-point increase in the PF-10 score between visit 1 and visit 2), - General condition of the patient, evaluated by the physician (PGE score) at visit 1 and visit 2- Patient satisfaction with Spiolto® Respimat® at visit 2
• Data analysis plan:
  Baseline data will be described using a cross-sectional approach. Data from the longitudinal follow-up will be summarized descriptively. Due to the nature of this non-interventional study, there is no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses are descriptive in nature and confidence intervals and p-values from statistical models are used for exploratory purposes. No adjustments for multiple testing are made in the evaluation of statistical significance. Consequently, significant differences may be observed by chance alone and p-values should be interpreted as exploratory and with caution.