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NCT01332344 Clinical Trial

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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01332344
Other study ID # 112604
Secondary ID
Status Completed
Phase N/A
First received March 4, 2010
Last updated June 1, 2017
Start date June 2009
Est. completion date June 2010

Study information
Verified date June 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5180
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fluticasone propionate/salmeterol combination
Asthma subjects newly prescribed fluticasone propionate/salmeterol combination
• Inhaled corticosteroids
asthma subjects newly prescribed inhaled corticosteroids in clinical practice

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the difference in asthma related exacerbations Asthma related exaceberation is defined as any asthma related emergency department visit, or inpatient visit or oral corticosteroid dispensing. 90 days post index
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