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:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL) Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids

  Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
• 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

• 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
• 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.