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

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Oglemilast; Drug: Placebo

• Registration Number: NCT00671073
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-05-02
• Study Start: 2008-05-05
• Primary Completion: 2009-05-15
• Study Completion: 2009-05-15
• Disposition First Submitted: 2012-03-01
• Disposition First Submitted QC: 2012-03-01
• Disposition First Posted: 2012-03-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 427

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Oglemilast	Oglemilast low dose, oral administration once daily for 12 weeks
4	Placebo	Placebo
3	Oglemilast	Oglemilast high dose, oral administration, once daily for 12 weeks.
2	Oglemilast	Oglemilast middle dose, oral administration, once daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)	After 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Pre-bronchodilator forced vital capacity (FVC)	After 12 weeks of treatment

Trial Locations

Locations (3)

Forest Investigative Site; 🇺🇸 Tacoma, Washington, United States

Forest Investigative Site WR1; 🇺🇸 Wheat Ridge, Colorado, United States

Forest Investigative Site WR2; 🇺🇸 Wheat Ridge, Colorado, United States