CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,677 enrolled
Drug / intervention
fluticasone propionate/salmeterol xinafoate combination +1 moredrug
Likely dose
Not stated in 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/NCT01332461
NCT01332461N/ACompleted

Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate-Salmeterol Combination Versus Other Maintenance Therapies

GlaxoSmithKline·observational·Posted Apr 11, 2011·Updated Jun 27, 2017

In Brief

An observational study evaluating fluticasone propionate/salmeterol xinafoate combination and Other maintenance Treatments (OMT) for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 5,677 participants.

Detailed Summary

This was a retrospective cross-sectional database study using administrative data (study period: 1/1/2003 through 7/31/2008). Managed care enrollees (aged \>40 years) having at least one Hospitalization with primary or secondary diagnosis of COPD (ICD code 491.xx, 492.xx and 496.xx) or at least one Emergency Room (ER) visit with primary diagnosis of COPD (index event) during the study period was the target population. All subjects were required to have one year of pre-index period baseline data. COPD events of interest were ER, Hospital and physician visits followed by oral corticosteroids (OCS) or antibiotics (Ab) within 7 days. Other censoring events were treatment switch; loss of enrollment; \>60-day gap between medication fills; or end of study period. This study is a non descriptive hypothesis testing study. Key study hypotheses are listed below. Specifically the study hypotheses for the primary outcome being tested were: Ho: There is no difference in risk of COPD-related hospitalization between FSC and OMT Ha: There is a difference in risk of COPD-related hospitalization between FSC and OMT Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between FSC and OMT Ha: There is a difference in COPD-related costs between FSC and OMT

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2011
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.2 years ago

Interventions

fluticasone propionate/salmeterol xinafoate combinationdrug

Patients filling a prescription for fluticasone/salmeterol combination as index drug

Other maintenance Treatments (OMT)drug

OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists