NCT01921127
Completed
Not Applicable
A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) vs. Fluticasone/Salmeterol (FSC) Combination in Patients With COPD.
ConditionsCOPD
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 3,000
- Primary Endpoint
- Rate of COPD exacerbation
Overview
Brief Summary
This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Continuous health plan enrollment for 12 months before and after index Rx, at least one prescription for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription.
Exclusion Criteria
- •ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC on the same day, patients diagnosed with cancer, patients with long-term OCS medication use during pre-index period.
Outcomes
Primary Outcomes
Rate of COPD exacerbation
Time Frame: 12 months
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.
Secondary Outcomes
- All-cause utilization(12 months)
- Treatment patterns and adherence(12 months)
- Treatment modification(12 months)
- COPD respiratory medication use(12 months)
- COPD related healthcare utilization(12 months)
- All- cause and COPD related healthcare costs(12 months)
- COPD exacerbation rate sensitivity analysis(up to 4 years)
- COPD exacerbation rate sensitivity and subgroup analyses(12 months)
Investigators
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