Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Oglemilast low dose, oral administration once daily for 12 weeks |
|
| 2 | Active Comparator | Oglemilast middle dose, oral administration, once daily for 12 weeks |
|
| 3 | Active Comparator | Oglemilast high dose, oral administration, once daily for 12 weeks. |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oglemilast | Drug | Oglemilast low dose, oral administration, once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) | After 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-bronchodilator forced vital capacity (FVC) | After 12 weeks of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian T Maurer, MS | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site | Birmingham | Alabama | 35215 | United States | ||
| Forest Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo, oral administration, once daily for 12 weeks |
|
| Oglemilast | Drug | Oglemilast middle dose, oral administration, once daily for 12 weeks |
|
|
| Oglemilast | Drug | Oglemilast high dose, oral administration, once daily for 12 weeks |
|
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Forest Investigative Site | Tucson | Arizona | 85715 | United States |
| Forest Investigative Site | Buena Park | California | 90620 | United States |
| Forest Investigative Site | Encinitas | California | 92024 | United States |
| Forest Investigative Site | Fullerton | California | 92835 | United States |
| Forest Investigative Site | Los Angeles | California | 90095 | United States |
| Forest Investigative Site | Orange | California | 92868 | United States |
| Forest Investigative Site | Rancho Mirage | California | 92270 | United States |
| Forest Investigative Site | San Diego | California | 92120 | United States |
| Forest Investigative Site | San Diego | California | 92134 | United States |
| Forest Investigative Site | Stockton | California | 95207 | United States |
| Forest Investigative Site | Centennial | Colorado | 80112 | United States |
| Forest Investigative Site WR1 | Wheat Ridge | Colorado | 80033 | United States |
| Forest Investigative Site WR2 | Wheat Ridge | Colorado | 80033 | United States |
| Forest Investigative Site | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative Site | Fort Lauderdale | Florida | 33316 | United States |
| Forest Investigative Site | Miami | Florida | 33155 | United States |
| Forest Investigative Site | Miami | Florida | 33169 | United States |
| Forest Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Forest Investigative Site | Tamarac | Florida | 33321 | United States |
| Forest Investigative Site | Skokie | Illinois | 60076 | United States |
| Forest Investigative Site | Evansville | Indiana | 47713 | United States |
| Forest Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Forest Investigative Site | Livonia | Michigan | 48152 | United States |
| Forest Investigative Site | Edina | Minnesota | 55437 | United States |
| Forest Investigative Site | Minneapolis | Minnesota | 55407 | United States |
| Forest Investigative Site | Papillion | Nebraska | 68046 | United States |
| Forest Investigative Site | Cherry Hill | New Jersey | 08003 | United States |
| Forest Investigative Site | Elmira | New York | 14901 | United States |
| Forest Investigative Site | Mineola | New York | 11501 | United States |
| Forest Investigative Site | Rochester | New York | 14618 | United States |
| Forest Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site | Toledo | Ohio | 43614 | United States |
| Forest Investigative Site | Medford | Oregon | 97504 | United States |
| Forest Investigative Site | Portland | Oregon | 97213 | United States |
| Forest Investigative Site | Bethlehem | Pennsylvania | 18020 | United States |
| Forest Investigative Site | Philadelphia | Pennsylvania | 19140 | United States |
| Forest Investigative Site | Charleston | South Carolina | 29406 | United States |
| Forest Investigative Site | Greenville | South Carolina | 29615 | United States |
| Forest Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Forest Investigative Site | El Paso | Texas | 79902 | United States |
| Forest Investigative Site | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site | Fredericksburg | Virginia | 22401 | United States |
| Forest Investigative Site | Tacoma | Washington | 98405 | United States |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C506613 | oglemilast |
Not provided
Not provided
Not provided