Asthma Comparative Effectiveness Study

Completed

• Conditions: Asthma

• Registration Number: NCT01623544
• Lead Sponsor: AstraZeneca

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2012-07
• Study Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6086

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asthma Related Emergency Department visits	12 months
Asthma Related Inpatient Hospitalizations	12 months
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.
Use of Oral Corticosteroids (OCS)	12 months	A pharmacy claim for any of the OCS medications

Secondary Outcome Measures

Name	Time	Method
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).
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.