Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)

Study type

• Study topic:
  Disease /health condition

  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:
  (R03AC12) salmeterol

  salmeterol

  (R03AC13) formoterol

  formoterol

  (R03AC18) indacaterol

  indacaterol

  (R03AK06) salmeterol and fluticasone

  salmeterol and fluticasone

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AK07) formoterol and budesonide

  formoterol and budesonide

  (R03AL05) formoterol and aclidinium bromide

  formoterol and aclidinium bromide

  (R03BB04) tiotropium bromide

  tiotropium bromide

  (R03BB05) aclidinium bromide

  aclidinium bromide

  (R03BB06) glycopyrronium bromide

  glycopyrronium bromide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  New users of aclidinium bromide (on monotherapy or with concomitant use of formoterol) and new users of other COPD medications will be identified and included in the specific exposure cohort of interest.; ; Inclusion Criteria; Patients in the study will be required to meet the following criteria, as ascertained from; each of the automated databases:;  To have at least 1 year of enrolment in the database (DUS1 and DUS2).;  To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1;  To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2 ; ; Exclusion Criteria; No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.
• 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:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  22500

Study design details

• Main study objective:
  Describe characteristics and patterns of use of new users of aclidinium bromide and other selected COPD treatments,Evaluate potential off-label use of aclidinium bromide,Describe users of aclidinium bromide in subgroups of patients for whom there is missing information in RMP,Establish a core cohort of new users of aclidinium bromide for future evaluation of safety concerns described in RMP
• Data analysis plan:
  The analysis will be descriptive and implemented in two phases:Phase 1. Baseline analysis: • Age and sex distribution of users • Proportion of patients with the above listed characteristics, comorbidities, and comedications for up to 1 year before the index date. • Proportion and description of patients with off-label use.Phase 2. Follow-up analysis: • Assessment of relevant comorbidities, pregnancies, and treatment patterns (duration, dose, and switching patterns) during 1 year after the index date.