CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1 enrolled
Drug / intervention
fluticasone propionate/salmeterol xinafoate +1 moredrug
Likely dose
fluticasone propionate/salmeterol xinafoate 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/NCT01337336
NCT01337336N/ACompleted

Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a Comorbid COPD-Depression/Anxiety Population

GlaxoSmithKline·observational·Posted Apr 18, 2011·Updated May 30, 2017

In Brief

An observational study evaluating fluticasone propionate/salmeterol xinafoate and Anticholinergics for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1 participant.

Detailed Summary

The objective of this study was to examine COPD-related outcomes for patients with comorbid depression/anxiety who are on combination fluticasone propionate/salmeterol xinafoate compared to those receiving anticholinergics. The prevalence of comorbid depression/anxiety in patients with chronic obstructive pulmonary disease (COPD) is estimated to be high and range from 10-40%, given that the risk of depression/anxiety symptoms is almost 3 times higher in patients with versus without COPD. Additionally, patients with comorbid COPD and depression/anxiety have higher COPD-related healthcare utilization and costs compared to those without depression/anxiety. Therapy with maintenance medications for COPD has been recommended to prevent future adverse COPD outcomes, but the impact of initiating these interventions has not yet been evaluated in a higher-risk population with comorbid COPD-depression/anxiety. The present study compares the risk of COPD exacerbations and COPD-related costs in patients initiating maintenance medications for treatment of COPD in a comorbid COPD/depression-anxiety population. Maintenance medications include inhaled corticosteroid (ICS), long-acting beta agonist (LABA), combination drug product of ICS+LABA, and anti-cholinergics (AC) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively abbreviated as IPR).

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 18, 2011
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.2 years ago

Interventions

fluticasone propionate/salmeterol xinafoatedrug

combination fluticasone priopionate and salmeterol xinafoate 250/50mcg

Anticholinergicsdrug

tiotropium; ipratropium alone; or ipratropium + albuterol