Real-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK primary care population - Study 1 (Real-life acceptability of Eklira)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

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

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 with COPD who changed their therapy from tiotropium to aclidinium bromide following its launch in the UK
• 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:
  100

Study design details

• Main study objective:
  To evaluate the real-life effectiveness of the antimuscarine bronchodilator aclidinium bromide (Eklira®) as part of a three-staged study following the launch of Eklira® in the UK. This first study involves characterising patients prescribed aclidinium bromide from tiotropium and determine the acceptabily of aclidinium by determining how many patients are satisfied with their change to aclidinium.
• Outcomes:
  The primary outcome for this study is the acceptability of change from tiotropium to aclidinium during the six-month outcome period.This is defined as the percentage of the patients changed to aclidinium bromide (received a prescription for aclidinium at date of first prescription) who did not receive ≥1 prescription for tiotropium during the outcome period. To provide real-world data on the utilisation of aclidinium bromide in clinical practice, the patients prescribed aclidinium bromide will be characterised following in the year prior to aclidinium bromide initiation. As the study aims to characterise the patients who are prescribed aclidinium, all patients will be characterised regardless of whether or not they change back to tiotropium.
• Data analysis plan:
  Summary statistics will be produced for all baseline variables. For variables measured on the interval or ratio scale, these will include:• Sample size (n)• Percentage non-missing• Mean • Variance / Standard Deviation• Range (Minimum / Maximum)• Median• Inter-quartile Range (25th and 75th percentiles)For categorical variables, the summary statistics will include:• Sample size (n)• Count and Percentage by category (distribution).Plots will be produced for all baseline variables. For variables measured on the interval or ratio scale, these will include:• Frequency plots • Box and whisker plots The data will be prepared for analysis by:• Investigating potential outliers,• Indentifying and creating new variables as necessary:o Transformations of skewed data (for example, log transformations),o Categorisation of heavily skewed data,• Investigating missing data (type of and reason for missingness).

Documents

Study results

REG_SUMMIT_abstract_FINAL_eklira_2014_11_14

Study publications

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying progn…