NCT01712334

A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis

A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	dornase alfa [Pulmozyme®]	Inhaled once daily by Pari eRapid nebulizer.
DRUG	dornase alfa [Pulmozyme®]	Inhaled once daily by Pari LC Plus jet nebulizer.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-10-23
• Last updated: 2014-05-01
• Results posted: 2014-05-01

Locations

16 sites across 1 country: United States