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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:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00671073
First received: April 29, 2008
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-bronchodilator forced vital capacity (FVC) [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671073

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00671073     History of Changes
Other Study ID Numbers: GRC-MD-50
Study First Received: April 29, 2008
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

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:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013