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 type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Measure changes in physical function

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  SPIOLTO
• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM

  OLODATEROL
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (46 to < 65 years)
    • Elderly (≥ 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

• 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
• 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