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A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis

2014-07-24 14:17:39 | BioPortfolio

Summary

This is a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, HRQOL, and respiratory symptoms in 3- to 5-year-old children with CF. After assessing their ability to participate, approximately 40 children will have baseline assessments before being randomized at approximately 5-8 sites across the United States. Children will receive approximately 16 days of study treatment.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

dornase alfa, placebo

Status

Terminated

Source

Genentech

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:17:39-0400

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Medical and Biotech [MESH] Definitions

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