Real-life effectiveness evaluation of asthma treatment in Korea

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

• Study drug International non-proprietary name (INN) or common name:
  FORMOTEROL FUMARATE

  BECLOMETASONE DIPROPIONATE

  FLUTICASONE PROPIONATE

  FLUTICASONE FUROATE

  SALMETEROL XINAFOATE
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Asthma patients that continue to collect prescriptions of new ICS/LABA pMDI after initial prescription.; Patients with following criteria were included:; (1) Codes for asthma (ICD-10) dependent on availability; (2) Aged 12-80 years at date of first prescription for LABA/ICS pMDI or a repeat prescription for LABA/ICS DPI; (3) Active asthma, defined as ≥ 2 prescriptions for LABA/ICS DPI at baseline; (4) ≥ 2 prescriptions for LABA/ICS during outcome period; (5) Same ICS dose at last prescription for LABA/ICS DPI at baseline and first prescription of LABA/ICS after switch date
• Age groups:
  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:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  Evaluating inhaler device ‘switch success’ and the real-life effectiveness in the Ajou University Hospital Database in Korea
• Outcomes:
  Switch success: Percentage of ICS/LABA pMDI patients who received ≥ 2 prescriptions of ICS/LABA pMDI (i.e. ≥ 1 prescription in addition to that issued at their prescription date) at 6 months and continued on ICS/LABA pMDI, i.e. did not fall back to ICS/LABA DPI. ICS doseTreatment successSABA usageOral steroid prescriptionSevere exacerbation rateRisk domain asthma controlOral thrush incidence
• Data analysis plan:
  Summary statistics will be produced for all baseline variables. The baseline variables for the two cohorts will be compared using the following tests:• Variables measured on the interval/ratio scale:− t-test (normal distribution)− Mann-Whitney U test (skewed data)• Categorical variables:− Chi-square testResults will be reported as: • Variables measured on the interval/ratio scale:− Sample size (n) and percentage non-missing− Median and inter-quartile range (25th and 75th percentiles)• Categorical variables:− Sample size (n)− Count and percentage by category (distributionIf sufficient numbers are achieved, patients will be matched on baseline variables to assess outcomes between the control (remain on DPI) against comparator (MDI)

Documents

Study results

R01116_Transfform_Ajou_FinalStudyReport_v1.0