AERIAL®: Changes in health and functional status in patients with COPD during therapy with Spiolto® Respimat®

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

• Medicinal product name:
  SPIOLTO RESPIMAT
• Medicinal product name, other:
  Spiolto Respimat
• 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

• Short description of the study population:
  Chronic obstructive pulmonary disease (COPD) patients receiving treatment with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
• 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:
  1300

Study design details

• Study design:
  This was an open-label observational study according to §4, section 23 and §67, section 6 German Medicines Act. All included COPD patients have been receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.;
• Main study objective:
  The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
• Setting:
  It was planned to collect data from approximately 1300 patients from approximately 400 sites in Germany in the period between Q2 2017 and Q2 2018. 1322 patients were registered at 114 sites with the first patient registered on March 31, 2017 and the last on November 10, 2018. Site selection was performed to reflect routine COPD care in Germany and to secure representativeness of the COPD population. Almost all sites were non-hospital (general practitioner and pulmonologists), one site was a pulmonology clinic. Patients were enrolled consecutively and followed over an observational period of approximately 6 weeks.
• Outcomes:
  Primary objective: Assess proportion of patients achieving “therapeutic success” (= 0.4 point decrease in the CCQ score between baseline and approximately week 6), Secondary objectives: Assessment of changes in CCQ and CCQ-4, patient’s general condition at visit 1 (baseline and at visit 2 (approx. 6 weeks after visit 1), patient satisfaction with Spiolto® Respimat®, willingness to continue treatment with Spiolto® Respimat® at visit 2 as proxy for adherence
• Data analysis plan:
  For the primary outcome, the proportion of patients with CCQ therapeutic success will be presented together with the 95% confidence interval.Patient’s general condition (PGE) at visit 1 and visit 2, patient satisfaction and willingness to continue treatment at visit 2 as categorical variables will be analyzed as tabulations of frequencies. Change from Visit 1 to Visit 2 in the CCQ and CCQ-4 score as continuous outcome 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 >20% of all patients.Subgroup analyses will be performed by GOLD spirometric classifications (2 vs. 3 vs. 4) and GOLD patient groups (B vs. C/D and B vs. C vs. D) for the primary outcome and changes in CCQ and CCQ-4 for the secondary outcome