A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 6,086
- Primary Endpoint
- Rate of asthma exacerbations
Overview
Brief Summary
The objective of this study is to compare the real-world effectiveness of BFC and FSC in asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan enrollees.
Detailed Description
A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 12 Years to 64 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Continuous health plan enrollment for 12 months before and after index Rx
- •At least two prescription fills for BFC or FSC within 12 months
- •Asthma claims diagnosis, and 12 to 64 years of age at the time of first prescription
Exclusion Criteria
- •Evidence of COPD
- •Claims diagnosis of any of inflammatory diseases or cancer
- •Presence of Rx for more than one type of ICS/LABA combination on index date
- •Chronic steroid use or Xolair use prior to ICS/LABA index treatment
Outcomes
Primary Outcomes
Rate of asthma exacerbations
Time Frame: 12 months
The rate is defined as the total number of asthma exacerbations for all patients in the cohort divided by the total number of person years. An asthma exacerbation is defined as any of three conditions: Asthma related inpatient hospitalization or Asthma related emergency department visit or Oral corticosteroid use.
Asthma Related Inpatient Hospitalizations
Time Frame: 12 months
Asthma Related Emergency Department visits
Time Frame: 12 months
Use of Oral Corticosteroids (OCS)
Time Frame: 12 months
A pharmacy claim for any of the OCS medications
Secondary Outcomes
- Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)(12 months)
- Asthma Related Healthcare Utilization(12 months)
- Asthma Related Healthcare costs(12 months)