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

Status:	Completed
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	6 - Any
Updated:	7/16/2013
Start Date:	January 2013
End Date:	June 2013
Contact:	Reference Study ID Number: ML28249 www.roche.com/about_roche/roche_worldwide.htm
Email:	global.rochegenentechtrials@roche.com
Phone:	888-662-6728 (U.S. Only)

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 eFlow Rapid Nebulizer System

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.

Inclusion Criteria:

- Male and female patients, >/= 6 years of age

- Confirmed diagnosis of cystic fibrosis (CF)

- Receiving Pulmozyme once daily chronically for treatment of CF for at least 6 months
prior to screening

- Percent predicted FEV1 >/= 40% at screening based on the Wang (males < 18 years,
females < 16 years) or Hankinson (males >/= 18 years, females >/= 16 years)
standardized equations

- Able to reproducibly perform spirometry testing and comply with study assessments

Exclusion Criteria:

- An acute respiratory infection or pulmonary exacerbation within 4 weeks prior to
randomization

- Initiation of any new chronic therapy (e.g. inhaled corticosteroids, inhaled oral
antibiotics, high-dose ibuprofen, hypertonic saline, ivacaftor) for respiratory
disease within 4 weeks prior to randomization

- Changes in chest physiotherapy schedule within 4 weeks prior to randomization

- Hospitalization within 4 weeks prior to randomization

- Planned hospitalization during the 6-week study

- History of organ transplantation

- Participation in an investigational drug or device study within 30 day prior to
screening

We found this trial at

sites

Clinical Trial Facility in Charleston South Carolina

Charleston, South Carolina 29412

from

Charleston, SC