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Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

NCT01431924 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7779

Last updated 2013-02-25

No results posted yet for this study

Summary

This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).

Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.

Conditions

Interventions

DRUG

Higher-dose inhaled corticosteroids

fluticasone propionate 110 or 220 mcg

DRUG

Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination

Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01431924 on ClinicalTrials.gov