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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