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

BUDESONIDE
FORMOTEROL FUMARATE
FLUTICASONE PROPIONATE
FLUTICASONE FUROATE
SALMETEROL XINAFOATE
BECLOMETASONE DIPROPIONATE MONOHYDRATE
BECLOMETASONE DIPROPIONATE

Medical condition to be studied

Asthma
Population studied

Short description of the study population

Asthma patients aged 12-80 years at date of first prescription for LABA/ICS pMDI or a repeat prescription for LABA/ICS DPI obtained from the Korean Health Insurance Review and Assessment (HIRA) service database.

Age groups

Infants and toddlers (28 days – 23 months)
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

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

2000
Study design details

Main study objective

To assess asthma outcomes in patients who switch from DPI to pMDI devices and who continue with DPI devices in Korea.

Outcomes

Switch persistance, defined as: Percentage of ICS/LABA pMDI patients who received ≥ 3 prescriptions of ICS/LABA pMDI in addition to that issued at their prescription date at 6 months, (a) % non-exacerbating patients of ‘switch’ cohort at 1 year, compared to baseline% of ‘switch’ cohort who have no severe exacerbations within 1 year of switching at 1 year, compared to year before switching (b) Severe asthma exacerbation rate (American Thoracic Society/European Respiratory Society statement definition) within the 1 year period

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 (distribution)Based on an expected “switch-back” probability of approximately 0.20 (20%) among patients switching from existing ICS/LABA DPI to ICS/LABA pMDI at their prescription date, a sample size of 100 patients per switch cohort would be sufficient to construct a 95% one-sided confidence interval with an upper bound of less than 0.30 (30%) to power the evaluation of ICS/LABA pMDI “switch success”