Clinical trial NCT00403286: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic
Obstructive
Pulmonary
Disease
COPD
Safety
Efficacy
Pharmacokinetic
Dose-finding
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 457
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 2-hour post-dose FEV1
timeFrame: 2 weeks
measure: AUC(0-12) and Cmax in plasma
timeFrame: 2 weeks
measure: pre-dose FEV1
timeFrame: 2 weeks
measure: Amount and percent total dose excreted in urine
timeFrame: 2 weeks
Secondary outcomes:
measure: FEV1 AUC(0-2)
timeFrame: 2 weeks
measure: COPD exacerbations
measure: Treatment Emergent Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Jasper
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Buena Park
country: United States
facility: Research Site
state: California
city: Costa Mesa
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Wheat Ridge
country: United States
facility: Research Site
state: Colorado
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Tamarac
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Woodstock
country: United States
facility: Research Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Research Site
state: Idaho
city: Hines
country: United States
facility: Research Site
state: Illinois
city: Lenexa
country: United States
facility: Research Site
state: Kansas
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Madisonville
country: United States
facility: Research Site
state: Kentucky
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: St. Charles
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Camillus
country: United States
facility: Research Site
state: New York
city: Liverpool
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Morrisville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: South Burlington
country: United States
facility: Research Site
state: Vermont
city: Abingdon
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References: