CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76,130 enrolled
Drug / intervention
fluticasone/salmeterol combination (FSC) 250/50mcg +2 moredrug
Likely dose
fluticasone/salmeterol combination (FSC) 250/50mcgfrom 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/NCT01331694
NCT01331694N/ACompleted

Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline·observational·Posted Apr 8, 2011·Updated Jul 2, 2017

In Brief

An observational study evaluating fluticasone/salmeterol combination (FSC) 250/50mcg, tiotropium, and 1 other intervention for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 76,130 participants.

Detailed Summary

To evaluate COPD-related clinical outcomes and total healthcare utilization in commercially insured (at least 40 years with a subanalysis of those aged 65 years and older) COPD population associated with the use of fluticasone/salmeterol combination (FSC) 250/50mcg compared to other initial maintenance therapies (IMTs), specifically, tiotropium bromide (TIO), and either ipratropium bromide or ipratropium bromide/albuterol (IP). This is a hypothesis testing study Ho: There is no difference in time to first COPD-related events between FSC and TIO and FSC and IP Ha: There is a difference in time to first COPD-related events between FSC and TIO and FSC and IP 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 TIO and FSC and IP Ha: There is a difference in COPD-related costs between FSC and TIO and FSC and IP

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 8, 2011
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.2 years ago

Interventions

fluticasone/salmeterol combination (FSC) 250/50mcgdrug

patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg

tiotropiumdrug

patients initiating treatment with tiotropium

ipratropium bromide alone or in fixed dose combination with albuteroldrug

patients initiating treatment with ipratropium/albuterol