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

Completed · Phase 4

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01712334

Run by

Genentech, Inc.

People needed

99

Starts

2012-12-01

Expected to finish

2013-06-01

Last updated by the study team

2014-05-01

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Boston, Massachusetts, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Long Branch, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Charleston, South Carolina, United States
• Study site — Sioux Falls, South Dakota, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Portland, Maine, United States

Full record on ClinicalTrials.gov

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