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Study of TNFR:Fc (Enbrel) in the Treatment of Asthma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Study of TNFR:Fc (Enbrel) in the Treatment of Asthma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study of TNFR:Fc (Enbrel) in the Treatment of Asthma Clinical research trials and Study of TNFR:Fc (Enbrel) in the Treatment of Asthma medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Study of TNFR:Fc (Enbrel) in the Treatment of Asthma. Study of TNFR:Fc (Enbrel) in the Treatment of Asthma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study of TNFR:Fc (Enbrel) in the Treatment of Asthma clinical trial. Participants oftentimes recieve the finest healthcare available for their Study of TNFR:Fc (Enbrel) in the Treatment of Asthma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Study of TNFR:Fc (Enbrel) in the Treatment of Asthma  Study of TNFR:Fc (Enbrel) in the Treatment of Asthma
Study of TNFR:Fc (Enbrel) in the Treatment of Asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen bronchoprovocation model of atopic asthma. The goal of this study is to assess whether inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind, placebo-controlled trial design. TNF bioactivity will be inhibited via systemic administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the extracellular ligand binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the utility of anti-TNF therapy for patients with asthma.
Details: The proposed study is a phase II clinical trial of TNFR:Fc therapy in a segmental allergen bronchoprovocation model of atopic asthma. The goal of this study is to assess whether inhibition of tumor necrosis factor (TNF) bioactivity can attenuate airway inflammation in mild-to-moderate allergic asthmatics. This protocol will utilize a randomized, double-blind, placebo-controlled trial design. TNF bioactivity will be inhibited via systemic administration (e.g., subcutaneous injection) of a dimeric fusion protein consisting of the extracellular ligand- binding domain of the 75-kilodalton TNF receptor linked to the Fc portion of human IgG1 (TNFR:Fc, Immunex). The data generated by this study will address the utility of anti-TNF therapy for patients with asthma.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients will be between 18 and 65 years of age, male or female, and must be at least 5 feet in height. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. Patients will have mild-to-moderate allergic asthma as defined by a baseline forced expiratory flow in one second (FEV(1)) greater than 70% of predicted (at least 6 hours after bronchodilator use) and therapy limited to inhaled beta-agonists. Patients must be without evidence of an asthma exacerbation or a viral upper respiratory tract infection for 6 weeks prior to entry into the study. Positive skin prick-puncture test to one or more common aeroallergens. A positive inhaled methacholine challenge as defined by a decrease in FEV(1) of at least 20% (PC20) in response to inhalation of less than 25 mg/ml of methacholine. A decrease in FEV(1) of at least 20% in response to inhalation of up to 10,000 bioequivalency allergy units (BAU) or allergy units (AU) per ml of a selected common aeroallergen (house dust mite, cat hair or grasses) or up to 150 Antigen E units per ml of short ragweed. Asthmatic patients must also demonstrate a late asthmatic response (defined as a 20% fall from the baseline established following completion of the early asthmatic response). Normal complete blood count, PT, PTT, and serum electrolytes, mineral and hepatic panels (less than 30 ml of blood will be drawn), normal EKG and chest radiograph without acute pulmonary infiltrates. For women of childbearing potential, negative pregnancy test with 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study. EXCLUSION CRITERIA: Hypersensitivity to TNFR:Fc Women who are breast-feeding infants will be excluded because the risk of a serious adverse reaction in the infants to TNFR:Fc is unknown. Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, bronchiectasis, HIV-related lymphocytic airway inflammation). Respiratory tract infection or asthma exacerbation within 4 weeks of screening. Presence of an active infection. Use of theophylline, oral or inhaled corticosteroid, nedocromil sodium, cromolyn sodium, zilueton, leukotriene receptor antagonists (e.g., zafirlukast or montelukast), or anti-cholinergic agents within the prior 3 months. In addition, patients requiring ongoing therapy with anti-histamines, hydroxyzine, and tricyclic anti-depressants will be excluded. Research subjects can continue therapy with inhaled beta-agonists during the study. History of anaphylaxis or severe allergic response. History of adverse reactions to lidocaine or other local anesthetics. Use of aspirin within 2 weeks of the bronchoscopic study or non-steroidal anti-inflammatory agents within 2 days of the bronchoscopic study. History of cigarette smoking within the past 3 years. History of allergy immunotherapy within the past year. Allergy to methacholine. Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation). Positive test for hepatitis viruses (to exclude patients with hepatitis-related lung disease, such as pleural effusions, interstitial pneumonitis and fibrosis). History of Crohn's disease (to exclude patients with inflammatory bowel disease-related alveolar lymphocytosis). History of diseases associated with impaired host defenses, such as diabetes mellitus or congestive heart failure. Patients with impaired host defenses also include individuals with either acquired or congenital, quantitative or qualitative defects in neutrophil, lymphocyte, monocyte/macrophage or complement function. Similarly, patients requiring immunosuppressive therapies, such as a chronic corticosteroid utilization for more than 6 months or cytoxic chemotherapeutic agents will be excluded. History of chronic heart failure or coronary artery disease. History of central nervous system demyelinating disorders, such as multiple sclerosis, myelitis or optic neuritis. History of hematologic disorders, such as anemia (other than iron deficiency anemia), thrombocytopenia or leukopenia. History of renal disease, such as chronic renal failure or renal artery stenosis with renal artery stent placement. History of psoriasis.
Total Enrollment: 150
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990140; 99-H-0140
Study Start Date: August 17, 1999
Record last reviewed: July 21, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001893
Other Asthma Studies:
1. Honolulu Heart Program
2. Development and Evaluation of Community Asthma Program
3. Pilot Study in Patients with Symptomatic Steroid-Naive Asthma
4. Asthma Clinical Research Network (ACRN)
5. Epidemiology of Idiopathic Dilated Cardiomyopathy (Washington, DC Dilated Cardiomyopathy Study)
Related Studies:
Other Asthma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of TNFR:Fc (Enbrel) in the Treatment of Asthma
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