Clinical trial NCT00215449: Study in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Keywords: Chronic Obstructive Pulmonary Disease
COPD
formoterol
formoterol fumarate
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 690
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 this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.


Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of COPD
* Current or prior history of cigarette smoking

Exclusion Criteria:

* Medical diagnosis of asthma
* Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
* Significant condition or disease other than COPD

Primary outcomes:
measure: Measure of lung function
Secondary outcomes:
measure: Change in lung function, as well as vital signs
measure: Physical Exam results, Adverse Event reporting, etc
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tuscon
country: United States
facility: Research Site
state: Arizona
city: Tuscon
country: United States
facility: Research Site
state: Arizona
city: Tuscon
country: United States
facility: Research Site
state: Arizona
city: Buena Park
country: United States
facility: Research Site
state: California
city: Encinitas
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mission Viejo
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Sepulveda
country: United States
facility: Research Site
state: California
city: Stockton
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Research Site
state: Colorado
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Bay Pines
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: DeLand
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: Blue Ridge
country: United States
facility: Research Site
state: Georgia
city: Hines
country: United States
facility: Research Site
state: Illinois
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Shawnee Mission
country: United States
facility: Research Site
state: Kansas
city: Topeka
country: United States
facility: Research Site
state: Kansas
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Slidell
country: United States
facility: Research Site
state: Louisiana
city: Edina
country: United States
facility: Research Site
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Minneapolis
country: United States
facility: Research Site
state: Minnesota
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Butte
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Papillion
country: United States
facility: Research Site
state: Nebraska
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Cherry Hill
country: United States
facility: Research Site
state: New Jersey
city: Springfield
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Larchmont
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: Chapel Hill
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: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Easton
country: United States
facility: Research Site
state: Pennsylvania
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
References:
citation: Donohue JF, Hanania NA, Fogarty C, Campbell SC, Rinehart M, Denis-Mize K. Long-term safety of nebulized formoterol: results of a twelve-month open-label clinical trial. Ther Adv Respir Dis. 2008 Aug;2(4):199-208. doi: 10.1177/1753465808093934.