Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

Asthma Clinical Trial

Official title:

Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332357
• Other study ID #: 112606
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: October 20, 2011
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6139
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Emergencies

Intervention

Drug:
• Fluticasone propionate/salmeterol combination ED MD
Receipt of fluticasone propionate/salmeterol combination from the ED physician
• Fluticasone propionate/salmeterol combination OP MD
Receipt of fluticasone propionate/salmeterol combination from the OP physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No