Asthma Comparative Effectiveness Study
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca
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.
Clinical Details
Official title: A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Rate of asthma exacerbationsAsthma Related Inpatient Hospitalizations Asthma Related Emergency Department visits Use of Oral Corticosteroids (OCS)
Secondary outcome: Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)Asthma Related Healthcare Utilization Asthma Related Healthcare costs
Detailed description:
A U. S. retrospective database analysis evaluating the comparative effectiveness of
budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
Eligibility
Minimum age: 12 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2012
Last updated: February 22, 2013
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