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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Oglemilast
* Drug: Placebo
* Drug: Oglemilast
* Drug: Oglemilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oglemilast low dose, oral administration once daily for 12 weeks | Drug: Oglemilast<br>* Oglemilast low dose, oral administration, once daily for 12 weeks<br>* Other names: GRC 3886;|
| Active Comparator: 2<br>Oglemilast middle dose, oral administration, once daily for 12 weeks | Drug: Oglemilast<br>* Oglemilast middle dose, oral administration, once daily for 12 weeks<br>* Other names: GRC 3886;|
| Active Comparator: 3<br>Oglemilast high dose, oral administration, once daily for 12 weeks. | Drug: Oglemilast<br>* Oglemilast high dose, oral administration, once daily for 12 weeks<br>* Other names: GRC 3886;|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Placebo, oral administration, once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) |  | After 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-bronchodilator forced vital capacity (FVC) |  | After 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD