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

September 11, 2019 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

427

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Forest Investigative Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Forest Investigative Site
      • Tucson, Arizona, United States, 85715
        • Forest Investigative Site
    • California
      • Buena Park, California, United States, 90620
        • Forest Investigative Site
      • Encinitas, California, United States, 92024
        • Forest Investigative Site
      • Fullerton, California, United States, 92835
        • Forest Investigative Site
      • Los Angeles, California, United States, 90095
        • Forest Investigative Site
      • Orange, California, United States, 92868
        • Forest Investigative Site
      • Rancho Mirage, California, United States, 92270
        • Forest Investigative Site
      • San Diego, California, United States, 92120
        • Forest Investigative Site
      • San Diego, California, United States, 92134
        • Forest Investigative Site
      • Stockton, California, United States, 95207
        • Forest Investigative Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Forest Investigative Site
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site WR1
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site WR2
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Forest Investigative Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Forest Investigative Site
      • Miami, Florida, United States, 33155
        • Forest Investigative Site
      • Miami, Florida, United States, 33169
        • Forest Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site
      • Tamarac, Florida, United States, 33321
        • Forest Investigative Site
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Forest Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Forest Investigative Site
    • Minnesota
      • Edina, Minnesota, United States, 55437
        • Forest Investigative Site
      • Minneapolis, Minnesota, United States, 55407
        • Forest Investigative Site
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Forest Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • Forest Investigative Site
    • New York
      • Elmira, New York, United States, 14901
        • Forest Investigative Site
      • Mineola, New York, United States, 11501
        • Forest Investigative Site
      • Rochester, New York, United States, 14618
        • Forest Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Forest Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Forest Investigative Site
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site
      • Toledo, Ohio, United States, 43614
        • Forest Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site
      • Portland, Oregon, United States, 97213
        • Forest Investigative Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18020
        • Forest Investigative Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Forest Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Forest Investigative Site
      • Greenville, South Carolina, United States, 29615
        • Forest Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site
    • Texas
      • El Paso, Texas, United States, 79902
        • Forest Investigative Site
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Forest Investigative Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 4
Placebo
Drug: Placebo
Placebo, oral administration, once daily for 12 weeks
ACTIVE_COMPARATOR: 1
Oglemilast low dose, oral administration once daily for 12 weeks
Drug: Oglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
ACTIVE_COMPARATOR: 2
Oglemilast middle dose, oral administration, once daily for 12 weeks
Drug: Oglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
ACTIVE_COMPARATOR: 3
Oglemilast high dose, oral administration, once daily for 12 weeks.
Drug: Oglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886
Drug: Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
Other Names:
  • GRC 3886

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Brian T Maurer, MS, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 5, 2008

Primary Completion (ACTUAL)

May 15, 2009

Study Completion (ACTUAL)

May 15, 2009

Study Registration Dates

First Submitted

April 29, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (ESTIMATE)

May 2, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRC-MD-50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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