This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.
Study Type
OBSERVATIONAL
Enrollment
3,000
Rate of COPD exacerbation
The rate of COPD exacerbation will be defined as the total number of COPD exacerbations during the post-index period for all patients in each treatment cohort divided by the total number of person years. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.
Time frame: 12 months
COPD exacerbation rate sensitivity and subgroup analyses
The following sensitivity and subgroup analyses will be performed for the primary outcome: Time to first COPD exacerbation, on-treatment analysis, switchers and non-switchers.
Time frame: 12 months
COPD respiratory medication use
COPD respiratory medication, use for BFC and FSC will be described in post-index period by presenting total number of COPD medication classes filled. Antibiotic use will be assessed overall and within 10 days of OCS Rx.
Time frame: 12 months
COPD related healthcare utilization
COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay, COPD related ICU admission and length of stay, COPD procedures.
Time frame: 12 months
All-cause utilization
Frequency of all-cause resource use of: inpatient hospitalizations and length of stay, ICU admissions and length of stay, and outpatient/office visits. Total number of different prescription medication classes filled will also be determined.
Time frame: 12 months
All- cause and COPD related healthcare costs
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Costs will be reported for the following resource uses: inpatient hospitalizations, ED visits, outpatient/office visits, skilled nursing facility, total medical, and prescriptions. Costs will be reported for all-cause as well as COPD related.
Time frame: 12 months
Treatment patterns and adherence
Continuity of care during the 12 months post-index period will be measured with the Bice and Boxerman index. Proportion of Days Covered (PDC) and Medication Possession Ratio (MPR) will be used to measure the compliance of the index-medication (Symbicort or Advair).
Time frame: 12 months
Treatment modification
COPD medication use, such as treatment changes, will be captured post-index.
Time frame: 12 months
COPD exacerbation rate sensitivity analysis
All COPD exacerbation rates will be captured during the entire patient follow-up (beyond 12 months of the post index period) for BFC and FSC
Time frame: up to 4 years