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Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Clinical research trials and Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) clinical trial. Participants oftentimes recieve the most expert healthcare available for their Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)  Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
For Condition: Pulmonary Disease, Chronic Obstructive,Emphysema,Chronic Bronchitis
Status: Recruiting
Sponsor(s): Centocor ,
Synopsis: The purpose of this study is to determine the safety and efficacy of infliximab in patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 40 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 225
Location and Contact Information:
2 Sites Participating *Recruiting*
Minneapolis, Minnesota,
United States
Recruiting
Additional Information:
Study ID Numbers: C0168T54;
Study Start Date: December 2002
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056264
Other Emphysema Studies:
1. Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
2. A blinded study comparing the safety and efficacy of a fully human anti-IL8 monoclonal antibody (ABX-IL8) to placebo in patients with chronic bronchitis and COPD
3. Effect of Ventilation-Feedback Training on Exercise Performance in COPD
4. Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD)
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Study Evaluating the Safety and Efficacy of Infliximab in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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