Real-world effectiveness of extrafine vesrus standard particle inhaled corticosteroids: A comparative effectiveness analysis of extrafine (EF) hydrofluoroalkane beclometasone (HFA-BDP) and Ciclesonide versus commonly prescribed standard particle inhaled corticosteroids for patients prescribed asthma therapy in The Netherlands (Extrafine vesrus stand particle ICS effectiveness)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  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:
  (R03BA) Glucocorticoids

  Glucocorticoids
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients prescribed asthma therapy in The Netherland who were 5-60 years old.; Patients aged 5-60 years who had received ≥ 2 prescriptions for asthma in their records at different points in time at any time AND/OR a diagnostic code for asthma – from hospital records or for patients with linked data from the general practice database, received current inhaled corticosteroids (ICS) therapy (First prescription at ID plus, ≥ 2 ICS prescription during the outcome period (and for increasing cohort only: ≥1 ICSprescription during the baseline period)), and at least one full year of baseline data (prior to the ID) and at least one full year of outcome data(following the ID) were included.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  11181

Study design details

• Main study objective:
  The aim of this study is to compare effectiveness (in terms of asthma control) of EF-ICS and SP-ICS therapies in patients from The Netherlands prescribed asthma therapy .
• Outcomes:
  Severe exacerbation:• Asthma-related hospital admissions AND• Prescription for acute courses of oral steroids Risk Domain Asthma Control (RDAC):• Absence of asthma-related hospital admissions OR• Absence of prescription for acute oral steroidsOverall Asthma Control:• Achieved RDAC AND • Average daily dose of ≤200mcg salbutamol / ≤500mcg terbutaline, Treatment stability:• Achieved RDAC• Addition of new therapy, including LTRA, THEO or LABA OR• ICS dose increase by ≥50%• Change ICS type and/or device (sensitivity definition only) Average daily SABA dose prescribed in the year following ICS therapy initiation, calculated as (Count of inhalers * doses per inhalers / 365) * mcg strength
• Data analysis plan:
  Patients will be matched on key baseline characteristics (t-test/chi square test, p<0.05). Residual confounders will be adjusted for in the statistical model (multivariate analyses, p<0.05). Initial ICS doses (FP-equivalents) will be compared through conditional logistic regression (p<0.05). Primary and secondary outcomes will be compared over the outcome period through conditional logistic regression (CLR) models. Results are expressed as Rate Ratio (RR)/ Odds Ratio (OR) with 95% confidence intervals (CI).