Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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)
Verified date | May 2013 |
Source | Dey |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 97 |
Est. completion date | May 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigative Site | Charlotte | North Carolina |
United States | Investigative Site | Greenville | South Carolina |
United States | Investigative Site | Madisonville | Kentucky |
United States | Investigative Site | Medford | Oregon |
United States | Investigative Site | Panama City | Florida |
United States | Investigative Site | San Antonio | Texas |
United States | Investigative Site | San Diego | California |
United States | Investigative Site | Spartanburg | South Carolina |
United States | Investigative Site | Spokane | Washington |
United States | Investigative Site | Sunset | Louisiana |
United States | Investigative Site | Tacoma | Washington |
United States | Investigative Site | Union | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Dey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma AUC(0-t) after 1 week of dosing | PK sampling over 24 hrs | Yes | |
Secondary | FEV1 | pre-dose and 2 hrs post-dose | No |
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