A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Status:
Terminated
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
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.