The purpose of this study is to determine the safety and efficacy of infliximab in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Condition	Treatment or Intervention	Phase
Pulmonary Disease, Chronic Obstructive Chronic Bronchitis Emphysema	Drug: Infliximab	Phase II

Further Study Details: 

Expected Total Enrollment:  225

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

To be eligible for the study, subjects must meet all of the following criteria:

• Have moderate or severe COPD by GOLD criteria
• Have at least one episode of COPD-related symptoms (eg, cough, sputum production, shortness of breath) within 2 months prior to screening
• Have a < 20% increase in FEV1 after a fixed dose of bronchodilator (180 mg inhaled albuterol)
• Are at least 40 years of age
• Have a history of >10 pack years of smoking (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent)
• Have a score of < 120 points on the CRQ.
• Men and women of childbearing potential must use adequate birth control measures
• Are considered eligible according to the TB screening, eligibility assessment, and prevention rules
• Are able to adhere to the study visit schedule and other protocol requirements
• Have provided signed, written informed consent prior to participation in the study

Exclusion Criteria:

If a subject has any of the following criteria, he or she may not be enrolled in the study:

• Have a > 20% variation between screening and baseline FEV1 assessments
• Have a pre-bronchodilator FEV1 <500mL.
• Have asthma as main component of their obstructive airway disease
• Have had a moderate or severe exacerbation of COPD within previous 1 month
• Have a SaO2 < 90% on room air
• Are being treated with long term oxygen therapy, requiring supplemental oxygen more often than on an occasional/as needed basis or requiring nocturnal positive pressure for sleep apnea
• Have New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF). .)
• Have a history of severe right sided heart failure or cor pulmonale
• Have participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to screening or plan to participate in pulmonary rehabilitation during the study
• Have a known alpha 1 antitrypsin deficiency
• Have had a serious infection (eg, hepatitis, pneumonia or pyelonephritis) within the previous 3 months
• Have had major surgery within the previous 3 months
• Women who are pregnant, nursing, or planning pregnancy within one year after screening
• Have used oral corticosteroids within 2 weeks of screening
• Have used an investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer
• Have been treated with any other therapeutic agent primarily targeted at reducing TNF (eg, pentoxifylline, thalidomide, etanercept, etc) within 3 months of screening
• Have previously received administration of infliximab
• Have a known allergy or significant reaction to murine products or chimeric proteins
• Are considered ineligible according to the TB screening, eligibility assessment, and prevention rules
• Have or have had an opportunistic infection (eg, herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
• Are known to be infected with human immunodeficiency virus (HIV)
• Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, mental, or cerebral disease (including demyelinating diseases such as multiple sclerosis)
• Have a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening)
• Have had a malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
• Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (ie, nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly
• Are known to have a current substance abuse (drug or alcohol) problem, other than nicotine

Alabama
      Birmingham,  Alabama,  United States
California
      San Diego,  California,  United States
      Torrance,  California,  United States
      Signal Hill,  California,  United States
      Berkeley,  California,  United States
      Anaheim,  California,  United States
Colorado
      Denver,  Colorado,  United States
Connecticut
      Hartford,  Connecticut,  United States
Florida
      Miami Beach,  Florida,  United States
      Bay Pines,  Florida,  United States
      Clearwater,  Florida,  United States
      Sarasota,  Florida,  United States
      St. Petersburg,  Florida,  United States
Georgia
      Blue Ridge,  Georgia,  United States
Louisiana
      New Orleans,  Louisiana,  United States
Maryland
      Baltimore,  Maryland,  United States
Massachusetts
      Springfield,  Massachusetts,  United States
      Worcester,  Massachusetts,  United States
Michigan
      Livonia,  Michigan,  United States
Minnesota
      2 Sites Participating, Minneapolis,  Minnesota,  United States
Missouri
      St. Charles,  Missouri,  United States
      St. Louis,  Missouri,  United States
Nebraska
      Omaha,  Nebraska,  United States
Nevada
      Las Vegas,  Nevada,  United States
New Hampshire
      Lebanon,  New Hampshire,  United States
New Jersey
      Bound Brook,  New Jersey,  United States
New York
      Endwell,  New York,  United States
      Mineola,  New York,  United States
      Larchmont,  New York,  United States
      New York,  New York,  United States
North Carolina
      Winston Salem,  North Carolina,  United States
      Raleigh,  North Carolina,  United States
      Chapel Hill,  North Carolina,  United States
      Charlotte,  North Carolina,  United States
Ohio
      Cincinnati,  Ohio,  United States
      Columbus,  Ohio,  United States
      Poland,  Ohio,  United States
Pennsylvania
      McKeesport,  Pennsylvania,  United States
      Philadelphia,  Pennsylvania,  United States
      Hershey,  Pennsylvania,  United States
South Carolina
      Columbia,  South Carolina,  United States
      Spartanburg,  South Carolina,  United States
      Charleston,  South Carolina,  United States
      Greer,  South Carolina,  United States
Tennessee
      Nashville,  Tennessee,  United States
Texas
      Amarillo,  Texas,  United States
      San Antonio,  Texas,  United States
      Dallas,  Texas,  United States
Virginia
      Virginia Beach,  Virginia,  United States
      Richmond,  Virginia,  United States
      Salem,  Virginia,  United States
Wisconsin
      Madison,  Wisconsin,  United States

Study ID Numbers:  C0168T54
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2003
ClinicalTrials.gov Identifier:  NCT00056264
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08