Asthma Comparative Effectiveness Study
Asthma CER
A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
1 other identifier
observational
6,086
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFebruary 25, 2013
February 1, 2013
1 month
June 18, 2012
February 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Rate of asthma exacerbations
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.
12 months
Asthma Related Inpatient Hospitalizations
12 months
Asthma Related Emergency Department visits
12 months
Use of Oral Corticosteroids (OCS)
A pharmacy claim for any of the OCS medications
12 months
Secondary Outcomes (3)
Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)
12 months
Asthma Related Healthcare Utilization
12 months
Asthma Related Healthcare costs
12 months
Study Arms (2)
Symbicort
BFC patients new to ICS/LABA combination therapy
Advair
FSC patients new to ICS/LABA combination therapy
Eligibility Criteria
Health plan members with asthma aged 12 to 64 years receiving two or more prescriptions for BFC or FSC during 6/1/2007-9/30/2010 who are naive to ICS/LABA combination therapy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Related Publications (1)
Tunceli O, Williams SA, Kern DM, Elhefni H, Pethick N, Wessman C, Zhou S, Trudo F. Comparative effectiveness of budesonide-formoterol combination and fluticasone-salmeterol combination for asthma management: a United States retrospective database analysis. J Allergy Clin Immunol Pract. 2014 Nov-Dec;2(6):719-26. doi: 10.1016/j.jaip.2014.07.016. Epub 2014 Oct 3.
PMID: 25439363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2012
First Posted
June 20, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2012
Study Completion
September 1, 2012
Last Updated
February 25, 2013
Record last verified: 2013-02