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Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01332357
Recruitment Status : Completed
First Posted : April 11, 2011
Results First Posted : October 13, 2011
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

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

Study Design
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Study Type : Observational
Actual Enrollment : 6139 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332357


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332357    
Other Study ID Numbers: 112606
First Posted: April 11, 2011    Key Record Dates
Results First Posted: October 13, 2011
Last Update Posted: July 6, 2017
Last Verified: June 2017
Keywords provided by GlaxoSmithKline:
fluticasone/propionate salmeterol combination
hospitalization
emergency department
asthma
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Fluticasone
Xhance
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics