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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oglemilast
Placebo
Oglemilast
Oglemilast
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site WR1
  • Forest Investigative Site WR2
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Oglemilast low dose, oral administration once daily for 12 weeks

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

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

Placebo

Outcomes

Primary Outcome Measures

Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)

Secondary Outcome Measures

Pre-bronchodilator forced vital capacity (FVC)

Full Information

First Posted
April 29, 2008
Last Updated
September 11, 2019
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00671073
Brief Title
Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2008 (undefined)
Primary Completion Date
May 15, 2009 (Actual)
Study Completion Date
May 15, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease, COPD, COAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Oglemilast low dose, oral administration once daily for 12 weeks
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oglemilast middle dose, oral administration, once daily for 12 weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
Oglemilast high dose, oral administration, once daily for 12 weeks.
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Oglemilast
Other Intervention Name(s)
GRC 3886
Intervention Description
Oglemilast low dose, oral administration, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral administration, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Oglemilast
Other Intervention Name(s)
GRC 3886
Intervention Description
Oglemilast middle dose, oral administration, once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Oglemilast
Other Intervention Name(s)
GRC 3886
Intervention Description
Oglemilast high dose, oral administration, once daily for 12 weeks
Primary Outcome Measure Information:
Title
Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1)
Time Frame
After 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Pre-bronchodilator forced vital capacity (FVC)
Time Frame
After 12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian T Maurer, MS
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Forest Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Forest Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Forest Investigative Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Forest Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Forest Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Forest Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Forest Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forest Investigative Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Forest Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Forest Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Facility Name
Forest Investigative Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Forest Investigative Site
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Forest Investigative Site WR1
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site WR2
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Forest Investigative Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Forest Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Forest Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Forest Investigative Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Forest Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Forest Investigative Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Forest Investigative Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Forest Investigative Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Forest Investigative Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Forest Investigative Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55437
Country
United States
Facility Name
Forest Investigative Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Forest Investigative Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
Forest Investigative Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Forest Investigative Site
City
Elmira
State/Province
New York
ZIP/Postal Code
14901
Country
United States
Facility Name
Forest Investigative Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Forest Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Forest Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Forest Investigative Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Forest Investigative Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Forest Investigative Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Forest Investigative Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
Country
United States
Facility Name
Forest Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Forest Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Forest Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Forest Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Forest Investigative Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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