Real-world effectiveness of extra-fine formulations in Denmark

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Historical cohort database study

Study drug and medical condition

• Name of medicine, other:
  Salbutamol Sterinebs, Ventolin Nebules
• 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:
  9273

Study design details

• Main study objective:
  The aim of this study is to compare Salbutamol SteriNebs® with its originator, Ventolin Nebules®. The primary objective is to assess whether effectiveness of Salbutamol SteriNebs® is non-inferior to that of Ventolin Nebules®.
• Outcomes:
  Primary outcome of this study is “effectiveness”, evaluated in terms of: (1) Severe COPD exacerbations (hospitalisations) in the outcome period, and(2) Moderate and severe COPD exacerbations in the outcome period. Please see the attached protocol for full definitions of these outcomes, Secondary outcome of this study is “safety”, evaluated in terms of Adverse Events (AEs). These will include AEs known to be related to Salbutamol SteriNebs® and Ventolin Nebules®, as specified in their respective summary of product characteristics. Please see the attached protocol for a fuller definition of this outcome.
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.Outcomes analyses: patients may be matched on demographics and key measures of disease severity to minimise confounding, using random selection process through SAS statistical software to avoid selection bias.Effectiveness and safety outcomes in the outcome period will be compared between treatment groups using a Conditional Poisson regression model. The model will use empirical standard errors (for more conservative confidence interval estimations) and adjustments will be made for potential baseline confounders. The adjusted rate ratio with 95% confidence interval will be reported.