|
Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis Clinical research trials and Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis. Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis clinical trial. Participants frequently get the best healthcare available for their Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis  Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
For Condition: Cystic Fibrosis,Bacterial Infection
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
Details: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 6 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening Sweat chloride at least 60 mEq/L --Prior/Concurrent Therapy-- At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic At least 4 weeks since prior administration of any investigational drug No concurrent antibiotics by aerosol --Patient Characteristics-- Renal: - Creatinine less than 2 mg/dL - BUN less than 40 mg/dL - No proteinuria of 2+ or greater Pulmonary: - FEV1 at least 75% and at least 25% of predicted - Room air oximetry at least 88% saturation - Able to perform pulmonary function tests - No hemoptysis of 60 mL or greater within 30 days prior to study - No abnormal chest X-ray Other: - Not pregnant - Fertile females must use effective contraception - No history of positive culture with Burkholderia cepacia - No history of glucose-6-phosphate dehydrogenase deficiency - No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
AlanMontgomery, Study Chair, Pathogenesis
Additional Information:
Study ID Numbers: 199/13390; PATH-PG-TNDS-002/003,PATH-FDR001235
Study Start Date: June 1995
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004829
Other Cystic Fibrosis Studies:
1. Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Clinical Trials
Other Clinical Trials
Phase III Randomized Study of the Inhalation of Tobramycin in Patients with Cystic Fibrosis
|
|
|
|
|
|
|
|
