Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
| NCT number | NCT00671073 |
| Other study ID # | GRC-MD-50 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 5, 2008 |
| Est. completion date | May 15, 2009 |
| Verified date | September 2019 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 427 |
| Est. completion date | May 15, 2009 |
| Est. primary completion date | May 15, 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Presence of COPD as defined by GOLD criteria (2006); post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 >30% and < 80% predicted - Current or former cigarette smoker Exclusion Criteria: - Long-term oxygen use of > 15 hours a day - Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms) - Any COPD exacerbations within 30 days prior to study entry or during run-in - History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months - Presence of clinical significant pulmonary disease other than COPD |
| Country | Name | City | State |
|---|---|---|---|
| United States | Forest Investigative Site | Bethlehem | Pennsylvania |
| United States | Forest Investigative Site | Birmingham | Alabama |
| United States | Forest Investigative Site | Buena Park | California |
| United States | Forest Investigative Site | Centennial | Colorado |
| United States | Forest Investigative Site | Charleston | South Carolina |
| United States | Forest Investigative Site | Charlotte | North Carolina |
| United States | Forest Investigative Site | Cherry Hill | New Jersey |
| United States | Forest Investigative Site | Cincinnati | Ohio |
| United States | Forest Investigative Site | Cincinnati | Ohio |
| United States | Forest Investigative Site | Edina | Minnesota |
| United States | Forest Investigative Site | El Paso | Texas |
| United States | Forest Investigative Site | Elmira | New York |
| United States | Forest Investigative Site | Encinitas | California |
| United States | Forest Investigative Site | Evansville | Indiana |
| United States | Forest Investigative Site | Fort Lauderdale | Florida |
| United States | Forest Investigative Site | Fredericksburg | Virginia |
| United States | Forest Investigative Site | Fullerton | California |
| United States | Forest Investigative Site | Greenville | South Carolina |
| United States | Forest Investigative Site | Livonia | Michigan |
| United States | Forest Investigative Site | Los Angeles | California |
| United States | Forest Investigative Site | Medford | Oregon |
| United States | Forest Investigative Site | Miami | Florida |
| United States | Forest Investigative Site | Miami | Florida |
| United States | Forest Investigative Site | Mineola | New York |
| United States | Forest Investigative Site | Minneapolis | Minnesota |
| United States | Forest Investigative Site | North Dartmouth | Massachusetts |
| United States | Forest Investigative Site | Orange | California |
| United States | Forest Investigative Site | Ormond Beach | Florida |
| United States | Forest Investigative Site | Papillion | Nebraska |
| United States | Forest Investigative Site | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site | Phoenix | Arizona |
| United States | Forest Investigative Site | Portland | Oregon |
| United States | Forest Investigative Site | Rancho Mirage | California |
| United States | Forest Investigative Site | Rochester | New York |
| United States | Forest Investigative Site | San Antonio | Texas |
| United States | Forest Investigative Site | San Diego | California |
| United States | Forest Investigative Site | San Diego | California |
| United States | Forest Investigative Site | Skokie | Illinois |
| United States | Forest Investigative Site | Spartanburg | South Carolina |
| United States | Forest Investigative Site | Stockton | California |
| United States | Forest Investigative Site | Tacoma | Washington |
| United States | Forest Investigative Site | Tamarac | Florida |
| United States | Forest Investigative Site | Toledo | Ohio |
| United States | Forest Investigative Site | Tucson | Arizona |
| United States | Forest Investigative Site | Waterbury | Connecticut |
| United States | Forest Investigative Site WR1 | Wheat Ridge | Colorado |
| United States | Forest Investigative Site WR2 | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) | After 12 weeks of treatment | ||
| Secondary | Pre-bronchodilator forced vital capacity (FVC) | After 12 weeks of treatment |
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