Incidence of oral thrush in COPD patients prescribed ICS as part of ICS/LABA therapy

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational study
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Symbicort, Seretide
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Chronic obstructive pulmonary disease (COPD) patients aged ≥ 40 years at first prescription (i.e. index date) for fixed-dose combination (FDC) inhaled corticosteroid (ICS)/ long-acting β2 agonist (LABA), or first prescription for or addition of long-acting bronchodilator, at least 2 years of continuous practice data (1 year of baseline and 1 year of outcome data), and ≥ 2 prescriptions for FDC ICS/LABA or long-acting bronchodilator during the outcome period (including the index date prescription).
• 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:
  22808

Study design details

• Main study objective:
  The aim of the study is two-fold: first, to investigate whether there is an association between ICS use as part of an FDC ICS/LABA and oral thrush in patients with COPD (Phase 1), and second, to assess whether this potential relationship between FDC ICS/LABA use and oral thrush is modulated by the ICS drug and dose within the prescribed FDC device (Phase 2).
• Outcomes:
  Incidence of oral thrush, defined as the proportion of patients with a diagnosis and/or prescribed medication for treating oral thrush within the outcome period.
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and for each matched cohort. All two-way comparisons of the primary outcome between treatment arms will be analysed using conditional logistic regression. Results will be reported as both: number (%) of patients diagnosed/prescribed therapy for oral thrush, and the odds ratio (95% CI), crude and adjusted for baseline predictors/confounders. The 5% level of significance will be used (two-tailed test).