DARWIN EU® -Drug utilisation of salbutamol products for inhalation and therapeutic alternative inhalation products

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (R03AC02) salbutamol

  salbutamol

Population studied

• Short description of the study population:
  The study cohort will include all individuals registered in the database between 1st of January 2015 and the most recent available data, with at least 365 days of data visibility prior to becoming eligible for study inclusion. This requirement of at least 365 days of prior data history will not hold for children <1 year of age.

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 7 databases. The study will comprise two consecutive parts: ; • A population-level cohort study ; • Patient-level characterisation study
• Main study objective:
  1. To describe the overall (i.e. all drug formulations combined) rate of prescribing inhaled salbutamol (irrespective of type of formulation) by calendar time (month, year). Monthly prescribing rates will be provided by database and healthcare setting (inpatient/outpatient). ; 2. To describe the rate of prescribing inhaled salbutamol by type of formulation and calendar time (year, month). Monthly prescribing rates will be provided by database and healthcare setting. ; 3. To describe the rate of prescribing other inhaled alternatives and oral salbutamol by calendar time (month, year). Monthly prescribing rates will be provided by database and healthcare setting. ; 4. To describe characteristics of individuals treated with inhaled salbutamol in terms of indication of use, sex and age (in age categories) stratified by formulation and provided by database and healthcare setting. ;
• Setting:
  This study will use routinely collected health data from 7 databases in the DARWIN EU® network of data partners from 6 European countries. All databases were previously mapped to the OMOP CDM.