Historical matched-cohort study assessing whether the use of inhaled corticosteroids shortens time to first diagnosis or accelerates the progression of side effects compared to non-ICS therapies in patients with Chronic Obstructive Pulmonary Disease. (ICS use in COPD patients and risk of side effects)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  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:
  (C05AA) Corticosteroids

  Corticosteroids
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Type 2 diabetes mellitus

  Osteoporosis

  Pneumonia

Population studied

• Short description of the study population:
  Patients with Chronic Obstructive Pulmonary Disease who were prescrived with Inhaled corticosteroids (ICS) or non-ICS therapies.; ; Patients with following criteria were included:; 1. Age ≥ 40 years at index date; 2. 2 years of continuous practice records, 1 year prior to index date and 1 year post index date; 3. ≥ 2 respiratory medication prescriptions per year of enrollment in the study; - ICS cohort: ≥ 2 ICS prescriptions per year4; - Non-ICS cohort: ≥ 2 of any of the following per year: SABA, LABA, SAMA, LAMA, Methylxanthines and/or compound bronchodilator preparations
• 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:
  100000

Study design details

• Main study objective:
  The objective is to analyze the relationship between ICS use and Type 2 Diabetes onset, Type 2 Diabetes worsening disease control and disease progression, osteoporosis onset, pneumonia incidence and overuse of ICS.
• Outcomes:
  The primary objective of the study is to evaluate whether ICS therapy is associated with an increased onset, shortened time to first diagnosis or accelerated progression of Type 2 Diabetes compared to non-ICS therapies. - To evaluate whether ICS are associated with an increased onset or shortened time to first diagnosis of osteoporosis or increased incidence of pneumonia compared to non-ICS therapies.- To evaluate the effects of average daily ICS dose, cumulative dose of ICS, ICS drug and inhaler device type on the aforementioned conditions.- To measure overuse of ICS in COPD patients according to guidelines.
• Data analysis plan:
  Summary statistics will be produced for unmatched and matched data for all baseline variables by group. Time to event outcomes will be analyzed using multivariable Cox proportional hazards models, reporting hazard ratios with 95% confidence intervals. Continuous progression outcomes will be analyzed using paired t-tests and generalized estimating equations reporting mean changes with 95% confidence intervals. Count outcomes will be analyzed using conditional Poisson regression, reporting incidence rate ratios with 95% confidence intervals.