A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Registration Number
- NCT01113593
- Lead Sponsor
- Dey
- Brief Summary
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Able to understand the requirements of the study and provide 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Formoterol Fumarate - 4 Foradil Aerolizer - 5 Foradil Aerolizer - 3 Formoterol Fumarate - 2 Formoterol Fumarate -
- Primary Outcome Measures
Name Time Method Forced expiratory volume at one second (FEV1) measured (in liters) by serial spirometry to compare dosing effect and characterize pharmacodynamic profile of Formoterol Fumarate and Foradil 12 hours on Day 1 and Day 7 of dosing during each treatment period
- Secondary Outcome Measures
Name Time Method