A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease
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
1 other identifier
interventional
457
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease
Started Nov 2006
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedJune 30, 2009
June 1, 2009
6 months
November 21, 2006
June 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
2-hour post-dose FEV1
2 weeks
AUC(0-12) and Cmax in plasma
2 weeks
pre-dose FEV1
2 weeks
Amount and percent total dose excreted in urine
2 weeks
Secondary Outcomes (3)
FEV1 AUC(0-2)
2 weeks
COPD exacerbations
Treatment Emergent Adverse Events
2 weeks
Study Arms (8)
C 10/1
EXPERIMENTALC 5/2
EXPERIMENTALC 5/1
EXPERIMENTALFP 1000
EXPERIMENTALFF 20
EXPERIMENTALAD 250/50
ACTIVE COMPARATORPlc
PLACEBO COMPARATORC 10/2
EXPERIMENTALInterventions
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Diagnosis of asthma
- Other significant disease than COPD
- Pregnant or lactating female
- Female planning to become pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (49)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Jasper, Alabama, 35501, United States
Research Site
Phoenix, Arizona, 85006, United States
Research Site
Buena Park, California, 90620, United States
Research Site
Costa Mesa, California, 92626, United States
Research Site
Encinitas, California, 92024, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
San Diego, California, 92120, United States
Research Site
Wheat Ridge, Colorado, 80033, United States
Research Site
Clearwater, Florida, 33765, United States
Research Site
DeLand, Florida, 32720, United States
Research Site
Tamarac, Florida, 33321, United States
Research Site
Tampa, Florida, 33603, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Woodstock, Georgia, 30189, United States
Research Site
Coeur d'Alene, Idaho, 83814, United States
Research Site
Hines, Illinois, 60141, United States
Research Site
Lenexa, Kansas, 66219, United States
Research Site
Topeka, Kansas, 66606, United States
Research Site
Madisonville, Kentucky, 42431, United States
Research Site
Wheaton, Maryland, 20902, United States
Research Site
Minneapolis, Minnesota, 55402, United States
Research Site
Saint Charles, Missouri, 63301, United States
Research Site
St Louis, Missouri, 63122, United States
Research Site
Henderson, Nevada, 89014, United States
Research Site
Cherry Hill, New Jersey, 08003, United States
Research Site
Albuquerque, New Mexico, 87108, United States
Research Site
Camillus, New York, 13031, United States
Research Site
Liverpool, New York, 13088, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Greenville, North Carolina, 29615, United States
Research Site
Morrisville, North Carolina, 27560, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Cincinnati, Ohio, 45227, United States
Research Site
Cincinnati, Ohio, 45231, United States
Research Site
Cincinnati, Ohio, 45242, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Medford, Oregon, 97504, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
East Providence, Rhode Island, 02914, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Austin, Texas, 78750, United States
Research Site
Dallas, Texas, 75231, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
South Burlington, Vermont, 05403, United States
Research Site
Abingdon, Virginia, 24210, United States
Research Site
Richmond, Virginia, 23225, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Milwaukee, Wisconsin, 53217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 23, 2006
Study Start
November 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 30, 2009
Record last verified: 2009-06