Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD
Brief summary
The purpose of this study is to characterize the pharmacodynamic profile of Formoterol Fumarate and Foradil Aerolizer
Interventions
DRUGFormoterol Fumarate
Inhalation solution
DRUGForadil Aerolizer
Dry powder inhaler
Sponsors
Dey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed