Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332357
First received: April 7, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Asthma
Drug: Fluticasone propionate/salmeterol combination ED MD
Drug: Fluticasone propionate/salmeterol combination OP MD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event [ Time Frame: Data were collected during a 4-year period from January 1, 2004 to December 31, 2008. ] [ Designated as safety issue: No ]
    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.


Enrollment: 6139
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Drug: Fluticasone propionate/salmeterol combination ED MD
Receipt of 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
Drug: Fluticasone propionate/salmeterol combination OP MD
Receipt of fluticasone propionate/salmeterol combination from the OP physician

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332357

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332357     History of Changes
Other Study ID Numbers: 112606
Study First Received: April 7, 2011
Results First Received: September 8, 2011
Last Updated: October 20, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
fluticasone/propionate salmeterol combination
hospitalization
emergency department
asthma

Additional relevant MeSH terms:
Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on April 17, 2014