Chronic Obstructive Pulmonary Disease Endpoints Study

A Randomized, Double-blind Placebo-controlled Study of Treatments With Salmeterol, Fluticasone Propionate and Their Combination to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358358

Enrollment

163

Registered

2006-07-31

Start date

2006-03-31

Completion date

2007-02-28

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD, Impulse Oscillometry System, Computerized Tomography

Brief summary

This study will last for approximately 14 weeks and will involve 5 visits. The study is being carried out to look at different ways of measuring the effect of drug treatment on COPD. COPD is a respiratory disease which can affect your breathing and daily life. Symptoms of COPD can include breathlessness, cough, and wheeze. COPD varies enormously from patient to patient. The effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your COPD is responding. In this study we therefore want to look at new and more sensitive ways of measuring COPD. The results of this research will help in the assessment of new drugs for COPD in the future.

Detailed description

Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination (FSC 500/50) and its individual components, Fluticasone Propionate 500mcg (FP500) and Salmeterol 50mcg (SAL 50)

Interventions

DRUGFluticasone Propionate/Salmeterol 500/50mcg combination

DRUGFluticasone Propionate 500mcg

DRUGSalmeterol 50mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD * Current or ex-smoker at least 10 pack- years

Exclusion criteria

* Diagnosis of asthma * Active respiratory disorder other than COPD * Evidence of clinically significant uncontrolled non-pulmonary disease * Carcinoma not in complete remission for last 5 years * Lung volume reduction surgery in previous 12 months * Nocturnal positive pressure for sleep apnea * Other inclusion and

Design outcomes

Primary

Measure	Time frame
Peripheral airway resistance measured by IOS	—

Secondary

Measure	Time frame
Airway wall thickness measured by CT scans	—

Countries

Chile, Estonia, Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026