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Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

FDA Office of Orphan Products Development · 1995
ClinicalTrials.gov · Datasets · License: Public Domain · 1995
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bacterial-infectioncystic-fibrosis
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.
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