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 RCV NIS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

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

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

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 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:
  7000

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:
  Primary outcomes:“Therapeutic success” at visit 2 (10-point increase in the PF-10 score between visit 1 and visit 2). Secondary outcomes:- Changes in the PF-10 score from visit 1 to 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:
  For the primary outcome, the proportion of patients with therapeutic success will be presented together with the 95% confidence interval. The patient’s general condition (PGE) at visit 1 and visit 2, mMRC at visit 1 and patient satisfaction at visit 2 are categorical variables so they will be analyzed as tabulations of frequencies. Change from visit 1 to visit 2 in the PF-10 score is a continuous outcome, so it will be analyzed with N / mean / SD / min / median / max.Subgroup analysis for maintenance naïve patients and the ones already treated at baseline with long acting bronchodilators (LABA only, LAMA only) or LABA + ICS will be performed for the primary outcome, if such subgroups include more than 20% of all patients.Subgroup analyses will be performed by GOLD spirometric classifications (2 vs. 3/4) and GOLD patient groups (B vs. C/D and B vs. C, vs. D) for the primary outcome and changes in PF-10 for the secondary outcome.