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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Inhaled once daily by Pari eRapid nebulizer.
Inhaled once daily by Pari LC Plus jet nebulizer.
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Portland, Maine, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Lebanon, New Hampshire, United States
Unnamed facility
Long Branch, New Jersey, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Akron, Ohio, United States
Unnamed facility
Cleveland, Ohio, United States
...and 6 more locations
Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.
Time frame: At the end of each 2-week treatment period
Safety: Number of Participants With Adverse Events During Each Treatment Period
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
Time frame: 4 Weeks
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