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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712334
Recruitment Status : Completed
First Posted : October 23, 2012
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: dornase alfa [Pulmozyme®] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: At the end of each 2-week treatment period ]
    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.

  2. Safety: Number of Participants With Adverse Events During Each Treatment Period [ Time Frame: 4 Weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712334


Locations
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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
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Genentech, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01712334    
Other Study ID Numbers: ML28249
First Posted: October 23, 2012    Key Record Dates
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases