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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


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 exacerbations

Asthma 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


Minimum age: 12 Years. Maximum age: 64 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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