This study will assess the safety and efficacy of a range of oglemilast doses. The study will be 14 weeks in duration. All patients meeting the eligibility criteria will be randomized to one of three doses of oglemilast or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
427
Oglemilast low dose, oral administration, once daily for 12 weeks
Placebo, oral administration, once daily for 12 weeks
Oglemilast middle dose, oral administration, once daily for 12 weeks
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
Time frame: After 12 weeks of treatment
Pre-bronchodilator forced vital capacity (FVC)
Time frame: After 12 weeks of treatment
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Oglemilast high dose, oral administration, once daily for 12 weeks
Forest Investigative Site
Birmingham, Alabama, United States
Forest Investigative Site
Phoenix, Arizona, United States
Forest Investigative Site
Tucson, Arizona, United States
Forest Investigative Site
Buena Park, California, United States
Forest Investigative Site
Encinitas, California, United States
Forest Investigative Site
Fullerton, California, United States
Forest Investigative Site
Los Angeles, California, United States
Forest Investigative Site
Orange, California, United States
Forest Investigative Site
Rancho Mirage, California, United States
Forest Investigative Site
San Diego, California, United States
...and 37 more locations