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Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis Clinical research trials and Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis. Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis clinical trial. Subjects typically recieve the finest healthcare available for their Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis  Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis
Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),University of Alabama
Synopsis: OBJECTIVES: Evaluate the efficacy and safety of lipid-mediated transfer of the cystic fibrosis transmembrane conductance regulator gene to nasal epithelium in patients with cystic fibrosis.
Details: PROTOCOL OUTLINE: Cystic fibrosis transmembrane conductance regulator (CFTR) gene complexed with lipid is administered intranasally to the right inferior turbinate. Lipid without CFTR is administered to the left nostril as a control. Cohorts of 3 patients are given successively lower doses of CFTR, each dose complexed with 500 micrograms of lipid. Patients are followed at days 2-12, 15, and 21, then every 3-4 days for 3 weeks, every 2-3 weeks for 10 weeks, and every 3 months thereafter.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Cystic fibrosis (CF), i.e.: Sweat chloride greater than 60 mEq/L Clinical manifestations of CF Homozygous delta F508 mutation preferred Compound heterozygotes for F508 mutation with pancreatic insufficiency eligible FEV1 greater than 40% of predicted PO2 at least 60 mm Hg on room air No acute or recurrent sinusitis No obstructive nasal polyposis No pneumothorax or hemoptysis, e.g., more than 250 mL blood within 24-hour period, within past year No unstable lung disease with worsening pulmonary symptoms, arterial blood gas, or pulmonary function tests within 2 weeks prior to entry No pulmonary exacerbation within 4 weeks prior to entry --Prior/Concurrent Therapy-- At least 2 months since participation in any other clinical study At least 2 months since DNase At least 4 months since corticosteroids --Patient Characteristics-- Cardiac: No severe cardiac disease Other: No other severe organ system disease, e.g., juvenile-type diabetes mellitus No pregnant women
Total Enrollment: 9
Location and Contact Information:
Overall Study Official:
EricSorscher, Study Chair, University of Alabama
Additional Information:
Study ID Numbers: 199/11983; UAB-11983
Study Start Date: June 1995
Record last reviewed: January 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004806
Other Cystic Fibrosis Studies:
1. Benefits and Risks of Newborn Screening for Cystic Fibrosis
2. Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis
3. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
4. Quantification of pulmonary neutrophil activity in cystic fibrosis using radiolabeled fluorodeoxyglucose and PET imaging
5. Studying Patients with Cystic Fibrosis and Other Pulmonary and Pancreatic Disorders
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Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis
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