Long-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised patients with Chronic Obstructive Pulmonary Disease (COPD) - a cohort study based on health information systems in three Italian regions (OUTPUL)

Study type

• Study topic:
  Human medicinal product

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

  Effectiveness study (incl. comparative)
• 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:
  (R03) DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

  (H02AB) Glucocorticoids

  Glucocorticoids

  (J01) ANTIBACTERIALS FOR SYSTEMIC USE

  ANTIBACTERIALS FOR SYSTEMIC USE
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients aged > 45years and resident in the study areas with acute exacerbation of COPD during a two-year period (2006-07)
• Age groups:
  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:
  40000

Study design details

• Main study objective:
  To measure long-term outcomes and adverse events of inhaled drugs in the study cohort over a 4-year follow up period, to compare effectiveness of the different drugs (both “monotherapy” and “combined therapy”) in terms of long-term survival or exacerbations, to compare the incidence of side effects of inhaled therapy (ICS, LABA and anticholinergics) among users versus non users.
• Outcomes:
  Mortality (All causes, respiratory causes, cardiovascular causes), COPD exacerbation defined as either a hospital admission/emergency visit for COPD or COPD-related causes or a prescription for an oral corticosteroids with/without systemic antibiotic, Adverse cardio- and cerebrovascular events, Pneumonia, Osteoporotic fractures
• Data analysis plan:
  Cox proportional hazard models will be applied to compare outcomes in users vs non-users of exposure to different drug groups (mono-/polytherapy). Sensitivity analyses will take into account different subgroup susceptibility or different definitions of chronic exposure.