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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332344
First received: March 4, 2010
Last updated: September 1, 2011
Last verified: August 2011
  Purpose

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 Intervention
Asthma
Drug: Fluticasone propionate/salmeterol combination
Drug: Inhaled corticosteroids

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the difference in asthma related exacerbations [ Time Frame: 90 days post index ] [ Designated as safety issue: No ]
    Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing.


Enrollment: 5180
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study intends to identify subjects with asthma treated with inhaled corticosteroids

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332344

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: NCT01332344     History of Changes
Other Study ID Numbers: 112604
Study First Received: March 4, 2010
Last Updated: September 1, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
fluticasone propionate/salmeterol combination
Asthma
inhaled corticosteroids
outcomes

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

ClinicalTrials.gov processed this record on September 30, 2014