Back to resultsA Dose-Finding Study Evaluating Safety and Efficacy 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
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate
Formoterol Fumarate
Fluticasone Propionate/Salmeterol Xinafoate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic, Obstructive, Pulmonary, Disease, COPD, Safety, Efficacy, Pharmacokinetic, Dose-finding
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD
- Female of child-bearing potential to use adequate birth control
- Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
- Meet lung function requirements
Exclusion Criteria:
- Diagnosis of asthma
- Other significant disease than COPD
- Pregnant or lactating female
- Female planning to become pregnant
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Experimental
Arm Label
C 10/1
C 5/2
C 5/1
FP 1000
FF 20
AD 250/50
Plc
C 10/2
Arm Description
Outcomes
Primary Outcome Measures
2-hour post-dose FEV1
AUC(0-12) and Cmax in plasma
pre-dose FEV1
Amount and percent total dose excreted in urine
Secondary Outcome Measures
FEV1 AUC(0-2)
COPD exacerbations
Treatment Emergent Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00403286
Brief Title
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease
Official Title
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of Fluticasone Propionate Combined With Formoterol Fumarate in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dey
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
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, Safety, Efficacy, Pharmacokinetic, Dose-finding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
457 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C 10/1
Arm Type
Experimental
Arm Title
C 5/2
Arm Type
Experimental
Arm Title
C 5/1
Arm Type
Experimental
Arm Title
FP 1000
Arm Type
Experimental
Arm Title
FF 20
Arm Type
Experimental
Arm Title
AD 250/50
Arm Type
Active Comparator
Arm Title
Plc
Arm Type
Placebo Comparator
Arm Title
C 10/2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Intervention Description
Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhalation Solution for nebulization 20 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Salmeterol Xinafoate
Intervention Description
Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhalation Solution for nebulization 2 mL bid for 2 weeks
Primary Outcome Measure Information:
Title
2-hour post-dose FEV1
Time Frame
2 weeks
Title
AUC(0-12) and Cmax in plasma
Time Frame
2 weeks
Title
pre-dose FEV1
Time Frame
2 weeks
Title
Amount and percent total dose excreted in urine
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
FEV1 AUC(0-2)
Time Frame
2 weeks
Title
COPD exacerbations
Title
Treatment Emergent Adverse Events
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
Female of child-bearing potential to use adequate birth control
Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day
Meet lung function requirements
Exclusion Criteria:
Diagnosis of asthma
Other significant disease than COPD
Pregnant or lactating female
Female planning to become pregnant
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Research Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Research Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Research Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Research Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Research Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Research Site
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Research Site
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Research Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Research Site
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Research Site
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Research Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Research Site
City
Camillus
State/Province
New York
ZIP/Postal Code
13031
Country
United States
Facility Name
Research Site
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Research Site
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Research Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Research Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease
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