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A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00774761

Last Updated: 2013-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

fluticasone propionate/formoterol fumarate

Intervention Type DRUG

inhalation suspension

2

Group Type EXPERIMENTAL

fluticasone propionate/formoterol fumarate

Intervention Type DRUG

inhalation suspension

3

Group Type ACTIVE_COMPARATOR

fluticasone propionate

Intervention Type DRUG

inhalation suspension

4

Group Type ACTIVE_COMPARATOR

fluticasone propionate

Intervention Type DRUG

inhalation suspension

5

Group Type ACTIVE_COMPARATOR

formoterol fumarate

Intervention Type DRUG

inhalation solution

Interventions

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fluticasone propionate/formoterol fumarate

inhalation suspension

Intervention Type DRUG

fluticasone propionate

inhalation suspension

Intervention Type DRUG

formoterol fumarate

inhalation solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Able to understand the requirements of the study and provide consent
* Medical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* Female of child-bearing potential to use adequate birth control

Exclusion Criteria

* Diagnosis of asthma
* Other significant disease than COPD
* Has donated a unit of blood within 30 days of study, or intends to donate
* QTc greater than 0.460 seconds
* Subjects who had radiation or chemotherapy in the previous 12 months
* Subjects who had lung resection
* History of illegal drug abuse or alcohol abuse within the past 5 years
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

San Diego, California, United States

Site Status

Investigative Site

Panama City, Florida, United States

Site Status

Investigative Site

Madisonville, Kentucky, United States

Site Status

Investigative Site

Sunset, Louisiana, United States

Site Status

Investigative Site

Charlotte, North Carolina, United States

Site Status

Investigative Site

Medford, Oregon, United States

Site Status

Investigative Site

Greenville, South Carolina, United States

Site Status

Investigative Site

Spartanburg, South Carolina, United States

Site Status

Investigative Site

Union, South Carolina, United States

Site Status

Investigative Site

San Antonio, Texas, United States

Site Status

Investigative Site

Spokane, Washington, United States

Site Status

Investigative Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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191-087

Identifier Type: -

Identifier Source: org_study_id

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