Outcomes in Patients Taking Fluticasone Propionate/Salmeterol Combination or Other Inhaled Corticosteroids
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332344
First received: March 4, 2010
Last updated: September 1, 2011
Last verified: August 2011
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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 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 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 Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013