A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00774761
- Lead Sponsor
- Dey
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 5 formoterol fumarate - 1 fluticasone propionate/formoterol fumarate - 2 fluticasone propionate/formoterol fumarate - 3 fluticasone propionate - 4 fluticasone propionate -
- Primary Outcome Measures
Name Time Method Plasma AUC(0-t) after 1 week of dosing PK sampling over 24 hrs
- Secondary Outcome Measures
Name Time Method FEV1 pre-dose and 2 hrs post-dose
Trial Locations
- Locations (1)
Investigative Site
🇺🇸Tacoma, Washington, United States