A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
NCT ID: NCT01712334
Last Updated: 2014-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
99 participants
INTERVENTIONAL
2012-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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eRapid Nebulizer
Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
dornase alfa [Pulmozyme®]
Inhaled once daily by Pari eRapid nebulizer.
Jet Nebulizer
Dornase alfa (Pulmozyme®) inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
dornase alfa [Pulmozyme®]
Inhaled once daily by Pari LC Plus jet nebulizer.
Interventions
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dornase alfa [Pulmozyme®]
Inhaled once daily by Pari eRapid nebulizer.
dornase alfa [Pulmozyme®]
Inhaled once daily by Pari LC Plus jet nebulizer.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Lebanon, New Hampshire, United States
Long Branch, New Jersey, United States
Rochester, New York, United States
Durham, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Countries
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References
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Yang C, Montgomery M. Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev. 2021 Mar 18;3(3):CD001127. doi: 10.1002/14651858.CD001127.pub5.
Sawicki GS, Chou W, Raimundo K, Trzaskoma B, Konstan MW. Randomized trial of efficacy and safety of dornase alfa delivered by eRapid nebulizer in cystic fibrosis patients. J Cyst Fibros. 2015 Nov;14(6):777-83. doi: 10.1016/j.jcf.2015.04.003. Epub 2015 Apr 25.
Other Identifiers
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ML28249
Identifier Type: -
Identifier Source: org_study_id
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