COMPARATIVE EFFECTIVENESS AND SAFETY OF BUDESONIDE STERINEBS® VS. PULMICORT RESPULES® IN A US POPULATION OF ASTHMA PATIENTS.

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

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Historical cohort database study

Study drug and medical condition

• Name of medicine, other:
  Budesonide Sterinebs, Pulmicort Respules
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  People who have been diagnosed with asthma and have been prescribed Pulmicort Respules®. Patients must meet the following criteria:; 1. Aged 1-80 years; Adult population: 12-80 years; Paediatric population: ≥1 and <12 years; 2. Diagnosis for asthma (at any time), based on ICD9 codes (Annex 1); 3. Change sub-cohort: ≥1 prescription for Pulmicort Respules® in baseline (1 year prior to IPD) and ≥1 prescriptions for Budesonide SteriNebs® at IPD; 4. Continuing sub-cohort: ≥1 prescription for Pulmicort Respules® during baseline (1 year prior to IPD) and ≥1 continued prescription for Pulmicort Respules® at IPD; 5. Initiation sub-cohorts: no prescriptions for ICS nebulisers in baseline (1 year prior to IPD) and ≥1 prescription for either Budesonide SteriNebs® or Pulmicort Respules® at IPD
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  13019

Study design details

• Main study objective:
  The aim of this study is to compare Budesonide SteriNebs® with its originator, Pulmicort Respules®. The primary objective is to assess whether effectiveness (in terms of exacerbations) of Budesonide SteriNebs® is non-inferior to that of Pulmicort Respules® in both adult and children diagnosed with asthma.
• Outcomes:
  Primary outcome of this study is "effectiveness", evaluated in terms of:(1) Asthma-related hospitalisation rate in the outcome period, and(2) Severe exacerbation (ATS/ERS definition) rate in the outcome period.Please see the attached protocol for full definitions of these outcomes, Secondary outcome of this study is "safety", evaluated in terms of Adverse Events (AEs).These will include AEs known to be related to Budesonide SteriNebs® and Palmicort Respules®, as specified in their respective summary of product characteristics. Please seethe attached protocol for a fuller definition of this outcome.
• Data analysis plan:
  Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.Outcomes analyses: patients may be matched on demographics and key measures ofdisease severity to minimise confounding, using random selection process through SASstatistical software to avoid selection bias.Effectiveness and safety outcomes in the outcome period will be compared betweentreatment groups using a Conditional Poisson regression model. The model will useempirical standard errors (for more conservative confidence interval estimations) andadjustments will be made for potential baseline confounders. The adjusted rate ratio with 95% confidence interval will be reported