An observational cohort study to describe intermittent OCS utilisation and its association with adverse outcomes and healthcare resource use and costs in asthma using the OPCRD and CPRD databases. (The burden of intermittent OCS use in asthma)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Healthcare resource utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Historical longitudinal descriptive study

Study drug and medical condition

• Medical condition to be studied:
  Asthma

  Type 2 diabetes mellitus

  Osteoporosis

  Osteoporotic fracture

  Hypertension

  Glaucoma

  Sleep apnoea syndrome

  Weight increased

  Depression

  Anxiety

  Pneumonia

  Cataract

  Chronic kidney disease

  Dyslipidaemia

  Peptic ulcer
• Additional medical condition(s):
  Sleep disorders, Cardiovascular disease, Growth suppression and behavioural disorders

Population studied

• Short description of the study population:
  The study population included patients aged 4 years or older received oral corticosteroids (OCS) for the treatment of asthma identified from the optimum patient care research database (OPCRD) and clinical practice research datalink (CPRD).; Inclusion Criteria: ; 1. OCS Arm - Patients with a prescription of an OCS with a concurrent (within 3 months) asthma event defined as an asthma QOF diagnosis or asthma QOF prescription. This will be the index date. ; 2. Non-OCS Arm - Patients with no OCS prescription at any time ; 3. Patients with at least 12 months baseline period (prior to index date) ; 4. Patients aged 4 or over at the index date; ; Exclusion Criteria: ; 1. Patients with a diagnosis, ever, for a chronic condition treated with OCS ; 2. Patients with a chronic AE outcome prior to the index date will be excluded from the analysis. This will ensure that the first chronic condition is the post index date incident event.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Patients with asthma
• Estimated number of subjects:
  1200000

Study design details

• Main study objective:
  1 To classify intermittent OCS prescriptions asthma patients and to describe by SABA and ICS use 2 To assess the association between patterns of intermittent OCS use and OCS-related adverse outcomes in patients with asthma. 3 To describe the impact of patterns of intermittent OCS use on the frequency of healthcare resource utilisation 4 To describe AEs for patients different average OCS doses
• Outcomes:
  Primary outcome will be a diagnosis of type 2 diabetes mellitus, osteoporosis/osteoporotic fractures, hypertension, glaucoma, sleep apnoea, weight gain and depression/anxiety, pneumonia, cataracts, sleep disorders, cardiovascular disease, chronic kidney disease, dyslipidaemia and peptic ulcer disease, and in the adolescent population we will look for growth suppression and behavioural disorders, Healthcare resource utilisation
• Data analysis plan:
  Objective 1: Baseline characteristics will be described for patients according to their longitudinal patterns of intermittent OCS use by GINA step, and ICS and SABA use. Objective 2: A matched historical cohort study will be performed with an assessment of potential confounders during a baseline period prior to the index date. Patients will be excluded if they had a record of the adverse event prior to their index date and categorised according to their patterns of OCS prescribing. Patients will be matched initially on gender, age, and the index date. Other potential confounders will be identified during the analysis, using potential bias assessments of covariates. Objective 3: HRU events will be described over the follow up period using the CPRD dataset. HRU events will be described in the baseline period and during the follow up for asthma-related and all-cause events using linked CPRD & HES. Objective 4: Describe the AE for patients with an average annual OCS doses.

Documents

Study results

Intermittent OCS Report v4.1 - clean

Study publications

Haughney J, Tran TN, Heatley H, Bourdin A, Menzies-Gow A, Jackson DJ, Maslova E…

Heatley H, Tran TN, Bourdin A, et al. Observational UK cohort study to describe…

Heatley H., Tran T., Bourdin A., Menzies-Gow A., Jackson D., Maslova E., Skinne…