Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
1 other identifier
observational
6,139
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 7, 2011
CompletedFirst Posted
Study publicly available on registry
April 11, 2011
CompletedResults Posted
Study results publicly available
October 13, 2011
CompletedJuly 6, 2017
June 1, 2017
1.1 years
April 7, 2011
September 8, 2011
June 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event
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.
Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.
Study Arms (2)
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
Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the OP physician
Interventions
Receipt of fluticasone propionate/salmeterol combination from the ED physician
Receipt of fluticasone propionate/salmeterol combination from the OP physician
Eligibility Criteria
The study intends to identify subjects with asthma discharged from an emergency department that received fluticasone propionate/salmeterol from either an ED physician or from an outpatient physician
You may qualify if:
- 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
You may not qualify if:
- Subjects with COPD or treatment for COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2011
First Posted
April 11, 2011
Study Start
June 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 6, 2017
Results First Posted
October 13, 2011
Record last verified: 2017-06