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
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
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
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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