Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone propionate/salmeterol combination ED MD; Drug: Fluticasone propionate/salmeterol combination OP MD

• Registration Number: NCT01332357
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-11
• Results First Submitted: 2011-09-08
• Results First Submitted QC: 2011-09-08
• Results First Posted: 2011-10-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6139

Inclusion Criteria

• Subjects with asthma as determined by ICD-9 codes and asthma drug use
• at least 12 years of age
• discharged from an initial Emergency Department visit within 12 months

Exclusion Criteria

• Subjects with COPD or treatment for COPD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fluticasone propionate/salmeterol combination ED MD	Fluticasone propionate/salmeterol combination ED MD	Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the ED physician
Fluticasone propionate/salmeterol combination OP MD	Fluticasone propionate/salmeterol combination OP MD	Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the OP physician

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event	Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.	A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.