A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
97
1 country
12
Brief Summary
The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Nov 2008
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
12 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
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 20, 2013
May 1, 2013
5 months
October 16, 2008
May 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma AUC(0-t) after 1 week of dosing
PK sampling over 24 hrs
Secondary Outcomes (1)
FEV1
pre-dose and 2 hrs post-dose
Study Arms (5)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATOR4
ACTIVE COMPARATOR5
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able to understand the requirements of the study and provide consent
- Medical diagnosis of COPD
- A current or prior history of at least 10-pack years of cigarette smoking
- Female of child-bearing potential to use adequate birth control
You may not qualify if:
- Diagnosis of asthma
- Other significant disease than COPD
- Has donated a unit of blood within 30 days of study, or intends to donate
- QTc greater than 0.460 seconds
- Subjects who had radiation or chemotherapy in the previous 12 months
- Subjects who had lung resection
- 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 (12)
Investigative Site
San Diego, California, 92120, United States
Investigative Site
Panama City, Florida, 32405, United States
Investigative Site
Madisonville, Kentucky, 42431, United States
Investigative Site
Sunset, Louisiana, 70584, United States
Investigative Site
Charlotte, North Carolina, 28207, United States
Investigative Site
Medford, Oregon, 97504, United States
Investigative Site
Greenville, South Carolina, 29615, United States
Investigative Site
Spartanburg, South Carolina, 29303, United States
Investigative Site
Union, South Carolina, 29379, United States
Investigative Site
San Antonio, Texas, 78205, United States
Investigative Site
Spokane, Washington, 99207, United States
Investigative Site
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
May 20, 2013
Record last verified: 2013-05