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

May 10, 2013 updated by: Dey

A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Investigative Site
    • Florida
      • Panama City, Florida, United States, 32405
        • Investigative Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Investigative Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Investigative Site
      • Union, South Carolina, United States, 29379
        • Investigative Site
    • Texas
      • San Antonio, Texas, United States, 78205
        • Investigative Site
    • Washington
      • Spokane, Washington, United States, 99207
        • Investigative Site
      • Tacoma, Washington, United States, 98405
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: fluticasone propionate/formoterol fumarate
inhalation suspension
Experimental: 2
Drug: fluticasone propionate/formoterol fumarate
inhalation suspension
Active Comparator: 3
Drug: fluticasone propionate
inhalation suspension
Active Comparator: 4
Drug: fluticasone propionate
inhalation suspension
Active Comparator: 5
Drug: formoterol fumarate
inhalation solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma AUC(0-t) after 1 week of dosing
Time Frame: PK sampling over 24 hrs
PK sampling over 24 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
FEV1
Time Frame: pre-dose and 2 hrs post-dose
pre-dose and 2 hrs post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 10, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191-087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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