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Completed

NCT Number: NCT00671073

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Forest Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oglemilast

Drug

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

Other names: GRC 3886

Placebo

Drug

Placebo, oral administration, once daily for 12 weeks

Primary outcomes

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

    Time frame: After 12 weeks of treatment

Secondary outcomes

  1. Pre-bronchodilator forced vital capacity (FVC)

    Time frame: After 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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