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
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Other
• If ‘other’, further details on the scope of the study:
  Measure changes in physical function
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPIOLTO RESPIMAT
• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM

  OLODATEROL
• 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

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  400

Study design details

• Study design:
  Open-label observational study, including COPD patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
• Main study objective:
  The primary 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
• Setting:
  Patients ‘data from 57 Spanish sites was collected (primary care centres). Sites were selected to reflect routine clinical practice for COPD in order to ensure the representativeness of the population with COPD.
• Outcomes:
  The primary objective is to evaluate the Physical Functioning based on Physical Functioning Questionnaire (PF-10)scores which consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities at visit 1 and at visit 2 with Spiolto® Respimat. The secondary objective is to evaluate the patient’s general condition (physician’s evaluation) at visit 1 (= baseline visit at the start of the study) and at visit 2 (= final visit approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
• Data analysis plan:
  All patients who have received at least one dose of Spiolto® Respimat® will be included in the analysis, 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.The assessment will be carried out using SAS® software. 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