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Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids

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. Identifier: NCT01332344
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):

Brief Summary:
The objective of this study is to compare healthcare utilization and costs in asthma patients who receive fluticasone propionate/salmeterol combination 100mcg/50mcg ("FSC 100/50") or inhaled corticosteriods in typical clinical practice using a retrospective observational cohort study design of large managed care database.

Condition or disease Intervention/treatment
Asthma Drug: Fluticasone propionate/salmeterol combination Drug: Inhaled corticosteroids

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Study Type : Observational
Actual Enrollment : 5180 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Healthcare Utilization and Costs in Patients With Asthma Who Fluticasone/Salmeterol Inhalation Powder Versus Other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data.
Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Group/Cohort Intervention/treatment
Asthma patients treated with inhaled corticosteroids
Asthma subjects newly prescribed inhaled corticosteriods
Drug: Fluticasone propionate/salmeterol combination
Asthma subjects newly prescribed fluticasone propionate/salmeterol combination

Drug: Inhaled corticosteroids
asthma subjects newly prescribed inhaled corticosteroids in clinical practice

Primary Outcome Measures :
  1. To assess the difference in asthma related exacerbations [ Time Frame: 90 days post index ]
    Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 65 Years   (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 treated with inhaled corticosteroids

Inclusion Criteria:

  • Subjects with asthma as determined by ICD-9 codes and asthma drug use
  • at least 12 years of age
  • treated with inhaled corticosteroids

Exclusion Criteria:

  • Subjects with COPD or treatment for COPD

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 identifier (NCT number): NCT01332344

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT01332344    
Other Study ID Numbers: 112604
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017
Keywords provided by GlaxoSmithKline:
fluticasone propionate/salmeterol combination
inhaled corticosteroids
Additional relevant MeSH terms:
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Salmeterol Xinafoate
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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