Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone propionate/salmeterol combination; Drug: Inhaled corticosteroids

• Registration Number: NCT01332344
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-03-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5180

Inclusion Criteria

• Subjects with asthma as determined by ICD-9 codes and asthma drug use
• at least 12 years of age
• treated with inhaled corticosteroids

Exclusion Criteria

• Subjects with COPD or treatment for COPD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asthma patients treated with inhaled corticosteroids	Fluticasone propionate/salmeterol combination	Asthma subjects newly prescribed inhaled corticosteriods
Asthma patients treated with inhaled corticosteroids	Inhaled corticosteroids	Asthma subjects newly prescribed inhaled corticosteriods

Primary Outcome Measures

Name	Time	Method
To assess the difference in asthma related exacerbations	90 days post index	Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.