Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00671073

Run by

Forest Laboratories

People needed

427

Starts

2008-05-05

Expected to finish

2009-05-15

Last updated by the study team

2019-09-19

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Forest Investigative Site — San Diego, California, United States
• Forest Investigative Site — Stockton, California, United States
• Forest Investigative Site — Centennial, Colorado, United States
• Forest Investigative Site WR1 — Wheat Ridge, Colorado, United States
• Forest Investigative Site WR2 — Wheat Ridge, Colorado, United States
• Forest Investigative Site — Waterbury, Connecticut, United States
• Forest Investigative Site — Fort Lauderdale, Florida, United States
• Forest Investigative Site — Miami, Florida, United States
• Forest Investigative Site — Miami, Florida, United States
• Forest Investigative Site — Ormond Beach, Florida, United States
• Forest Investigative Site — Tamarac, Florida, United States
• Forest Investigative Site — Skokie, Illinois, United States
• Forest Investigative Site — Evansville, Indiana, United States
• Forest Investigative Site — North Dartmouth, Massachusetts, United States
• Forest Investigative Site — Livonia, Michigan, United States

Full record on ClinicalTrials.gov

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