A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
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
1 other identifier
interventional
468
1 country
23
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.
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 Aug 2010
23 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
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 23, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMay 27, 2013
May 1, 2013
Same day
July 21, 2010
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 Weeks
Secondary Outcomes (1)
Incidence of adverse events (AEs)
12 Weeks
Study Arms (7)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
ACTIVE COMPARATOR7
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (23)
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Fullerton, California, United States
Investigative Site
San Diego, California, United States
Investigative Site
Clearwater, Florida, United States
Investigative Site
DeLand, Florida, United States
Investigative Site
Tamarac, Florida, United States
Investigative Site
Lawrenceville, Georgia, United States
Investigative Site
Coeur d'Alene, Idaho, United States
Investigative Site
Madisonville, Kentucky, United States
Investigative Site
Sunset, Louisiana, United States
Investigative Site
St Louis, Missouri, United States
Investigative Site
Charlotte, North Carolina, United States
Investigative Site
Raleigh, North Carolina, United States
Investigative site
Sylvania, Ohio, United States
Investigative Site
Medford, Oregon, United States
Investigative Site
Easley, South Carolina, United States
Investigative Site
Gaffney, South Carolina, United States
Investigative Site
Greenville, South Carolina, United States
Investigative Site
Greer, South Carolina, United States
Investigative Site
Spartanburg, South Carolina, United States
Invesigative Site
Union, South Carolina, United States
Investigative Site
San Antonio, Texas, United States
Investigative Site
Spokane, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 23, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2010
Study Completion
October 1, 2011
Last Updated
May 27, 2013
Record last verified: 2013-05