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A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis Clinical research trials and A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis clinical trial. Human subjects often receive the most effective healthcare possible for their A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis  A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , National Center for Research Resources (NCRR)
Synopsis: This study's primary goals are to test the safety and effectiveness of Tobramycin for Inhalation (TOBIr) in cystic fibrosis (CF) patients who are between 6 months and 6 years of age. This drug is an antibiotic that is inhaled into the lungs by the patient. It has already been studied and approved by the FDA for treatment of CF patients 6 years and older. Lung fluid will be examined for bacteria before and after the 28-day treatment. The amount of bacteria before and after treatment will be compared. This will indicate whether the antibiotic was effective in killing bacteria in the lungs. Once treatment begins, patients will be monitored every 2 weeks throughout the study (5 exams in 56 days). Half of the patients will receive TOBIr, half will receive a placebo (a substance that looks like TOBIr but contains no medication).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 6 Months/5 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age at least 6 months and less than 6 years - Diagnosis of cystic fibrosis with 2 clinical features consistent with CF and confirmed by either sweat chloride >= 60 mEq/L (by quantitative pilocarpine iontophoresis) or by genotype with 2 identifiable mutations consistent with CF. - One throat or sputum microbiology culture positive for Pseudomonas aeruginosa (Pa) within 2 weeks to 12 months prior to screening. - Informed consent by parent or legal guardian. Exclusion Criteria: - History of adverse reaction to anesthesia or sedation. - History of aminoglycoside hypersensitivity. - History of unresolved anemia (hematocrit < 30%) or thrombocytopenia (platelet count < 100,000/mm3). - History of hemoptysis with 30 days prior to screening. - History of abnormal renal function (serum creatinine > 1.5 times the upper limit of normal for age). - History of clinically documented chronic hearing loss. - Administration of any investigational drug within 30 days prior to screening.
Total Enrollment: 98
Location and Contact Information:
Overall Study Official:
JeffreyWagener, Principal Investigator, The Children's Hospital
Stanford University/Lucille Packard Children's Health Services at Stanford
Palo Alto, California, 94304
United States
Children's Hospital
Boston, Massachusetts, 02115
United States
The Children's Hospital
Denver, Colorado, 80218
United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: Inhaled Tobramycin in CF; M01 RR 00037,1-R01-DK57755-01
Study Start Date: February 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006280
Other Cystic Fibrosis Studies:
1. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
2. Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis
3. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis
4. Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients with Cystic Fibrosis
5. Diabetes Therapy to Improve BMI and Lung Function in CF
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis
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