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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluticasone propionate/formoterol fumarate
fluticasone propionate
formoterol fumarate
Sponsored by
Dey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

Outcomes

Primary Outcome Measures

Plasma AUC(0-t) after 1 week of dosing

Secondary Outcome Measures

FEV1

Full Information

First Posted
October 16, 2008
Last Updated
May 10, 2013
Sponsor
Dey
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1. Study Identification

Unique Protocol Identification Number
NCT00774761
Brief Title
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic, Obstructive, Pulmonary, Disease, COPD, Pharmacodynamic, Pharmacokinetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Active Comparator
Arm Title
5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate/formoterol fumarate
Intervention Description
inhalation suspension
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate
Intervention Description
inhalation suspension
Intervention Type
Drug
Intervention Name(s)
formoterol fumarate
Intervention Description
inhalation solution
Primary Outcome Measure Information:
Title
Plasma AUC(0-t) after 1 week of dosing
Time Frame
PK sampling over 24 hrs
Secondary Outcome Measure Information:
Title
FEV1
Time Frame
pre-dose and 2 hrs post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Investigative Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Investigative Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Investigative Site
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigative Site
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Investigative Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Investigative Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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

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