Asthma Comparative Effectiveness Study

A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01623544

Acronym

Asthma CER

Enrollment

6086

Registered

2012-06-20

Start date

2012-06-30

Completion date

2012-09-30

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Comparative Effectiveness, Symbicort

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Rate of asthma exacerbations	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	12 months	—
Asthma Related Emergency Department visits	12 months	—
Use of Oral Corticosteroids (OCS)	12 months	A pharmacy claim for any of the OCS medications

Secondary

Measure	Time frame	Description
Asthma Related Healthcare Utilization	12 months	Asthma Related Healthcare Utilization: Outpatient/office visits, Inpatient length of stay, ICU admission and length of stay.
Asthma Related Healthcare costs	12 months	Asthma Related Healthcare costs (plan paid, patient paid and plan + patient paid)costs of all Asthma related medication and Asthma related outpatient/office, ED and Inpatient visits.
Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)	12 months	Asthma controller use (0 vs. 1 and total number of fills for each).

Outcome results