NCT00680316

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

A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic Fibrosis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study assessments but did not have usable pulmonary function test (PFT) data.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Dornase alfa	2.5 mL (2.5 mg) dornase alfa nebulized once daily for 16 (+/-2) days
DRUG	Placebo	2.5 mL (2.5 mg) placebo nebulized once daily for 16 (+/-2) days

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-05-20
• Last updated: 2017-01-12
• Results posted: 2011-06-17