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GM-CSF in Patients With Pulmonary Alveolar Proteinosis 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 GM-CSF in Patients With Pulmonary Alveolar Proteinosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. GM-CSF in Patients With Pulmonary Alveolar Proteinosis Clinical research trials and GM-CSF in Patients With Pulmonary Alveolar Proteinosis 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 GM-CSF in Patients With Pulmonary Alveolar Proteinosis. GM-CSF in Patients With Pulmonary Alveolar Proteinosis 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 GM-CSF in Patients With Pulmonary Alveolar Proteinosis clinical trial. Participants oftentimes recieve the finest healthcare available for their GM-CSF in Patients With Pulmonary Alveolar Proteinosis 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 > "G" Clinical Trials Conditions > GM-CSF in Patients With Pulmonary Alveolar Proteinosis  GM-CSF in Patients With Pulmonary Alveolar Proteinosis
GM-CSF in Patients With Pulmonary Alveolar Proteinosis
For Condition: Pulmonary Alveolar Proteinosis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a study to determine the efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered subcutaneously to patients with pulmonary alveolar proteinosis (PAP).
Details: PAP is a rare lung disease characterized by accumulation of surfactant phospholipids and proteins within the lungs. There is no specific pharmacologic therapy for PAP and the current practice of lung lavage under general anesthesia is invasive and has limitations. Although it is unknown if the anti GM-CSF antibody is related to the disease pathogenesis, observations suggest a role for GM-CSF in lung homeostasis as well as in the pathogenesis of PAP. Patients will receive subcutaneous GM-CSF or placebo once a day and will be followed on an outpatient basis at 2 weeks, and 1, 2, 3, 4, 5 and 6 months after initiation of therapy. Clinical response will determine dosing schedule and will be evaluated by symptom scores, gas exchange data, and chest radiographs.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Diagnosis of primary or idiopathic PAP - Creatinine no greater than 2 mg/dL - Bilirubin no greater than 2 mg/dL - Liver enzymes no greater than 3 times normal - Women must use an effective method of contraception, be post menopausal, or be surgically sterilized Exclusion criteria: - Active respiratory infection - Active cardiovascular disease (e.g., cardiogenic pulmonary edema) - Underlying myeloproliferative disorder or leukemia - Other secondary cause of PAP (e.g., occupational exposure to silica or HIV with PCP) - At increased risk of side effects from GM-CSF therapy (i.e., rheumatoid arthritis, immune thrombocytopenia, or autoimmune thyroiditis) - Previous therapy with GM-CSF - Pregnant or nursing - Significant renal or liver disease
Total Enrollment: 48
Location and Contact Information:
National Jewish Medical Center *Recruiting*
Denver, Colorado,
United States
Recruiting
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting
The University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting
Additional Information:
Study ID Numbers: FD-R-002016; FD-R-002016-01
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030056
Other Pulmonary Alveolar Proteinosis Studies:
1. GM-CSF in Patients With Pulmonary Alveolar Proteinosis
Related Studies:
Other Pulmonary Alveolar Proteinosis Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
GM-CSF in Patients With Pulmonary Alveolar Proteinosis
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