Describing inhaler errors when mixing various inhaler types on inhaler technique in Chronic Obstructive Pulmonary Disease (COPD): MISMATCH study

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• 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:
  584

Study design details

• Main study objective:
  To compare the nature and frequency of inhaler technique errors, by describing all errors observed rather than using pre-determined checklists, between two groups of patients with COPD: 1. Patients using a combination of a DPI and a pMDI (“Mixed-devices group”) 2. Patients using a single DPI (“DPI only group”)
• Outcomes:
  Type of inhaler technique error, COPD health status, measured as the Clinical COPD Questionnaire (CCQ) score and COPD Assessment Test (CAT) score Number of COPD exacerbations in the last year
• Data analysis plan:
  Distributions of inhaler technique errors (numbers and percentages) will be described for the total population and will be compared, and differences statistically tested, between two groups of patients: 1. Patients using a combination of a DPI and a pMDI (“Mixed-devices group”) 2. Patients using a single DPI (“DPI only group”) Balanced matching on the type of DPI-device will be used to control potential confounding of the association between the use of mixed-devices and occurrence of inhaler errors by device-type. Mixed effects logistic regression models will be used to adjust the associations between errors occurrence and the group for other potential confounders. Effect sizes will be expressed as Odds Ratios with 95% confidence intervals.