CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17,448 enrolled
Drug / intervention
fluticasone propionate/salmeterol xinafoate combination +1 moredrug
Likely dose
fluticasone propionate/salmeterol xinafoate combination 100mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01347060
NCT01347060N/ACompleted

Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

GlaxoSmithKline·observational·Posted May 4, 2011·Updated May 25, 2017

In Brief

An observational study evaluating fluticasone propionate/salmeterol xinafoate combination and inhaled corticosteroids for Asthma. Completed, enrolled 17,448 participants.

Detailed Summary

The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged \>65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2011
Enrollment StartJul 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.2 years ago

Interventions

fluticasone propionate/salmeterol xinafoate combinationdrug

Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)

inhaled corticosteroidsdrug

Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide