Asthma Comparative Effectiveness Study

Asthma Clinical Trial

— Asthma CER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623544
• Other study ID #: RWE-000015
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2012
• Last updated: February 22, 2013
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: RWEstudies: Not applicable
• Study type: Observational

Clinical Trial 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.

Description:

A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6086
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 64 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Asthma Related Inpatient Hospitalizations		12 months	No
Primary	Asthma Related Emergency Department visits		12 months	No
Primary	Use of Oral Corticosteroids (OCS)	A pharmacy claim for any of the OCS medications	12 months	No
Secondary	Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)	Asthma controller use (0 vs. 1 and total number of fills for each).	12 months	No
Secondary	Asthma Related Healthcare Utilization	Asthma Related Healthcare Utilization: Outpatient/office visits, Inpatient length of stay, ICU admission and length of stay.	12 months	No
Secondary	Asthma Related Healthcare costs	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.	12 months	No