A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: At the end of each 2-week treatment period ] [ Designated as safety issue: No ]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.
- Safety: Number of Participants With Adverse Events During Each Treatment Period [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: eRapid Nebulizer
Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
Drug: dornase alfa [Pulmozyme®]
Inhaled once daily by Pari eRapid nebulizer.
Active Comparator: Jet Nebulizer
Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
Drug: dornase alfa [Pulmozyme®]
Inhaled once daily by Pari LC Plus jet nebulizer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712334
|United States, Arizona|
|Phoenix, Arizona, United States, 85016|
|United States, Arkansas|
|Little Rock, Arkansas, United States, 72202|
|United States, Maine|
|Portland, Maine, United States, 4102|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|United States, New Hampshire|
|Lebanon, New Hampshire, United States, 03756|
|United States, New Jersey|
|Long Branch, New Jersey, United States, 07740|
|United States, New York|
|Rochester, New York, United States, 14618|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Akron, Ohio, United States, 44308|
|Cleveland, Ohio, United States, 44106|
|United States, South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, South Dakota|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-9119|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Salt Lake City, Utah, United States, 84132|
|United States, Washington|
|Seattle, Washington, United States, 98105|
|Study Director:||Clinical Trials||Genentech|