At a glance
ClinicalIndex Comparison Record- ✓Age less than 30 months
- ✓CF diagnosis confirmed by either two sweat chlorides >60 mEq/L or two identifiable CF mutations on genotype
- ✕Prior treatment with Pulmozyme
- ✕Hospitalization or IV antibiotic treatment within 14 days of initial study visit
- ✕Acute intercurrent respiratory infection within preceding 48 hours (fever >38°C, new upper respiratory symptoms, increased cough/wheezing/respiratory rate)
- ✕Oxyhemoglobin saturation <90% on room air
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Pulmozyme in Infants and Young Children With Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating Recombinant Human DNase (Pulmozyme) and Placebos for Cystic Fibrosis. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.
Study Details
Timeline
Interventions
2.5 mg in 3 ml diluent delivered by nebulization given daily for 6 months with 3 ml diluent placebo delivered by nebulization given daily for 6 months
2.5 ml sterile solution (8.77 mg/ml sodium chloride, 0.15 mg/ml calcium chloride, pH 7.0 +/- 2.0) delivered daily by nebulization for 6 months, either preceding or following 6 months of Pulmozyme depending on randomization of the subject