Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD
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.
Interventions
DRUGOglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
DRUGPlacebo
Placebo, oral administration, once daily for 12 weeks
Sponsors
Forest Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) | After 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pre-bronchodilator forced vital capacity (FVC) | After 12 weeks of treatment |
Countries
United States
Outcome results
None listed