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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671073
First Posted: May 2, 2008
Last Update Posted: March 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose
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.

Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive Drug: Oglemilast Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Dose-Ranging Study of the Efficacy and Safety of Oglemilast in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Pre-bronchodilator morning (trough) forced expiratory volume in 1 second (FEV1) [ Time Frame: After 12 weeks of treatment ]

Secondary Outcome Measures:
  • Pre-bronchodilator forced vital capacity (FVC) [ Time Frame: After 12 weeks of treatment ]

Enrollment: 427
Study Start Date: April 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: GRC 3886
Active Comparator: 2
Oglemilast middle dose, oral administration, once daily for 12 weeks
Drug: Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
Other Name: GRC 3886
Active Comparator: 3
Oglemilast high dose, oral administration, once daily for 12 weeks.
Drug: Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
Other Name: GRC 3886
Placebo Comparator: 4
Placebo
Drug: Placebo
Placebo, oral administration, once daily for 12 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671073


  Show 47 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Brian T Maurer, MS Forest Laboratories
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00671073     History of Changes
Other Study ID Numbers: GRC-MD-50
First Submitted: April 29, 2008
First Posted: May 2, 2008
Last Update Posted: March 5, 2012
Last Verified: March 2012

Keywords provided by Forest Laboratories:
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
COPD
COAD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes