Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
1 other identifier
interventional
427
1 country
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2008
Shorter than P25 for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2008
CompletedFirst Posted
Study publicly available on registry
May 2, 2008
CompletedStudy Start
First participant enrolled
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2009
CompletedSeptember 19, 2019
September 1, 2019
1 year
April 29, 2008
September 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
After 12 weeks of treatment
Secondary Outcomes (1)
Pre-bronchodilator forced vital capacity (FVC)
After 12 weeks of treatment
Study Arms (4)
1
ACTIVE COMPARATOROglemilast low dose, oral administration once daily for 12 weeks
2
ACTIVE COMPARATOROglemilast middle dose, oral administration, once daily for 12 weeks
3
ACTIVE COMPARATOROglemilast high dose, oral administration, once daily for 12 weeks.
4
PLACEBO COMPARATORPlacebo
Interventions
Oglemilast low dose, oral administration, once daily for 12 weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Forest Investigative Site
Birmingham, Alabama, 35215, United States
Forest Investigative Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brian T Maurer, MS
Forest Laboratories
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2008
First Posted
May 2, 2008
Study Start
May 5, 2008
Primary Completion
May 15, 2009
Study Completion
May 15, 2009
Last Updated
September 19, 2019
Record last verified: 2019-09