Clinical trial NCT01168310: A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary, Obstructive, lungs, COPD
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 468
Sex: ALL
Minimum age (years): 40
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.


Eligibility criteria: Inclusion Criteria:

* Able to understand the requirements of the study and provide written informed consent
* A clinical diagnosis of COPD
* A current or prior history of at least 10-pack years of cigarette smoking
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

* A clinical diagnosis of Asthma
* Other significant disease than COPD
* Subjects who radiation or chemotherapy within the previous 12 months
* Subjects who had any lung resection
* QTcB greater than 0.460 seconds
* History of illegal drug abuse or alcohol abuse within the past 5 years

Primary outcomes:
measure: Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD
timeFrame: 12 Weeks
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Fullerton
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Clearwater
country: United States
facility: Investigative Site
state: Florida
city: Deland
country: United States
facility: Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Investigative Site
state: Florida
city: Lawrenceville
country: United States
facility: Investigative Site
state: Georgia
city: Coeur D'Alene
country: United States
facility: Investigative Site
state: Idaho
city: Madisonville
country: United States
facility: Investigative Site
state: Kentucky
city: Sunset
country: United States
facility: Investigative Site
state: Louisiana
city: Saint Louis
country: United States
facility: Investigative Site
state: Missouri
city: Charlotte
country: United States
facility: Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigative Site
state: North Carolina
city: Sylvania
country: United States
facility: Investigative site
state: Ohio
city: Medford
country: United States
facility: Investigative Site
state: Oregon
city: Easley
country: United States
facility: Investigative Site
state: South Carolina
city: Gaffney
country: United States
facility: Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Investigative Site
state: South Carolina
city: Union
country: United States
facility: Invesigative Site
state: South Carolina
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Spokane
country: United States
facility: Investigative Site
state: Washington
Study officials:
References: