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 (SPIRIT)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SPIOLTO RESPIMAT
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide
• Medical condition to be studied:
  Bronchial obstruction

Population studied

• Short description of the study population:
  Chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat®.
• 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:
  2000

Study design details

• Study design:
  Open-label prospective observational study according to §4, section 23 and §67, section 6 German Medicines Act: all included COPD patients received treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
• Main study objective:
  to measure changes in physical functioning -as a surrogate for physical activity and exercise capacity- in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks
• Setting:
  Between February 2016 and February 2017, 258 German investigational sites, mainly office-based pulmonologists and general practitioners, participated in NIS Spirit. The first patient was registered on 11 Feb 2016 and the last patient on 20 Feb 2017. Last patient last visit (LPLV) was on 06 Mar 2017.
• Outcomes:
  Primary objective: Measure changes in physical functioning by PF-10 questionnaire in COPD patients treated with Spiolto Respimat after ca. 6 weeks in routine clinical practice, 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 at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
• Data analysis plan:
  Primary outcome: “therapeutic success” at visit 2.(10-point increase in the PF-10 score between visit 1 and visit 2).Secondary outcomes:Change 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.Subgroup analysis for maintenance naïve patients and the ones alreadytreated at baseline with long acting bronchodilators or LABA + ICSwill be performed for the primary outcome.Subgroup analyses will be performed by GOLD spirometricclassifications (2 vs. 3/4) and GOLD patient groups (B vs. C/D and Bvs. C vs. D) for the primary endpoint and changes in PF-10 for thesecondary outcome.