Evaluation of patients with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who would benefit from aclidinium bromide treatment

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective observational database study

Study drug and medical condition

• Name of medicine:
  EKLIRA
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients aged ≥ 40 years who were diagnosed with chronic obstructive pulmonary disease (COPD) or chronic kidney disease (CKD)
• 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:
  Renal impaired

  Other
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  1670

Study design details

• Main study objective:
  To characterise populations of patients with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who could benefit from treatment with aclidinium bromide as an alternative to Tiotropium
• Outcomes:
  To characterise the aclidinium bromide eligible population. The proportion of patients who are being incorrectly treated with tiotropium and the proportion of patients not receiving any LAMA therapy but that would be justified in having treatment, and could therefore be started on aclidinium bromide, will be evaluated.
• Data analysis plan:
  Summary statistics will be calculated for the following variables by LAMA therapy and compared:• Demographics (including age, sex, BMI, smoking status)• Co-morbidities• Number of exacerbations in the year before the index date (ATS and clinical definition)• GOLD group status• CKD diagnostic codeFor variables measured on the interval or ratio scale, summary statistics produced will be:• Sample size (n)• Percentage non missing• Mean• Variance/standard deviation• Range (minimum- maximum)• Median• Inter-quantile range (25th and 75th percentile)For categorical variable the summary statistics will include:• Sample size (n)• Range (if applicable)• Count and percentage by category (distribution)Outcomes will be compared using a Mann Whitney U test/Chi squared Test (for variables measured on the interval or ratio scale/ categorical variables respectively.)