Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease

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

Official Title

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group, Dose Finding Study Evaluating the Safety and Efficacy of Infliximab Administration in Symptomatic Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions

– Pulmonary Disease, Chronic Obstructive- Chronic Bronchitis- Emphysema

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

Eligibility & Criteria

Ages Eligible for Study: 40 Years and above, Genders Eligible for Study: Both Criteria Inclusion CriteriaTo 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.

Total Enrolment

225

Contact Details

[1] Centocor