COPD
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, COPD, formoterol, formoterol fumarate
Brief summary
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.
Interventions
DRUGFormoterol Fumarate
Sponsors
Dey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical diagnosis of COPD * Current or prior history of cigarette smoking
Exclusion criteria
* Medical diagnosis of asthma * Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD * Significant condition or disease other than COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure of lung function | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lung function, as well as vital signs | — |
| Physical Exam results, Adverse Event reporting, etc | — |
Countries
United States
Outcome results
None listed