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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: Oglemilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00671073

GRC-MD-50

Details and patient eligibility

About

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.

Enrollment: 427 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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427 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Oglemilast low dose, oral administration once daily for 12 weeks

Treatment:

Drug: Oglemilast

Drug: Oglemilast

Drug: Oglemilast

2

Active Comparator group

Description:

Oglemilast middle dose, oral administration, once daily for 12 weeks

Treatment:

Drug: Oglemilast

Drug: Oglemilast

Drug: Oglemilast

3

Active Comparator group

Description:

Oglemilast high dose, oral administration, once daily for 12 weeks.

Treatment:

Drug: Oglemilast

Drug: Oglemilast

Drug: Oglemilast

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo