Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is characterized by chronic airflow limitation
caused by inflammation-mediated damage to lung tissue. Although damage to lung tissue in
COPD appears to be irreversible, evidence suggests that the course of COPD can be altered
through measures such as smoking cessation, pulmonary rehabilitation, and the use of
pharmacotherapy for bronchodilation. A primary goal of maintenance pharmacotherapy is to
reduce the incidence of acute exacerbations and the associated hospitalizations and
emergency department (ED) visits. Bronchodilation in COPD maintenance therapy can be
accomplished with the long-acting anticholinergic tiotropium (TIO), long acting
beta-agonists (e.g. formoterol, salmeterol), methylxanthines (e.g. theophylline), or
combination therapy with a long-acting beta-agonist and an inhaled corticosteroid (e.g.
fluticasone propionate/salmeterol [FSC]).
The objective of this study is to compare the benefits of combination long-acting
beta-agonist/inhaled corticosteroid therapy to long-acting anticholinergic therapy. The
study compares the risk of COPD exacerbations and COPD-related healthcare utilization and
costs for commercially-insured patients age 40 and older who were prescribed FSC to those
prescribed TIO. The null hypothesis is that no difference exists between the costs and
outcomes of COPD patients treated with TIO and those treated with FSC. The test hypothesis
is that patients treated with either TIO or FSC will incur lower costs and use fewer
healthcare resources for the management of COPD.
The source of data for this study was the Ingenix Impact database (formerly the Integrated
Healthcare Information Services [IHCIS] database). This is an administrative claims database
that includes patient-level data on enrollment, facility, professional, and pharmacy
services from approximately 50 million patients covered by more than 40 managed care health
plans across the United States (US).
The study design is a retrospective cohort study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
| Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
| Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
| Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
| Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
| Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
| Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
| Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
| Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
| Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
| Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
| Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
| Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
| Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
| Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|