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Study Name: PULMOZYME delivered by the eRapid Nebulizer
Study Type: Interventional
Intervention Category: Mucus Alteration
Study Sponsor: Genentech
Study Phase: 4
Recruitment Status: Trial Completed
Study Drug(s): Pulmozyme
Number of Participants Being Recruited: 80
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This trial will evaluate the effectiveness and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in people with cystic fibrosis. People with CF who have been taking Pulmozyme once a day for at least 6 months will continue to take Pulmozyme once a day for a 2 weeks using the Pari LC Plus nebulizer. People with CF will then be randomized to take in a crossover design Pulmozyme once a day 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.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= 40 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Potential study subjects must already be regularly using pulmozyme on a once daily schedule (for at least 6 monthe prior to study entry)
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01712334
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AR
  • Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
    Contact Information:
        Ramsey, Lacey LeAnn
        Phone: (501) 364-2391
        Email: LRamsey@uams.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
ME
  • Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
    Contact Information:
        Milliard, Carrie
        Phone: (207) 662-6712
        Email: millic@mmc.org
NC
  • Duke University Medical Center (Pediatric), Durham, NC, 27710
    Contact Information:
        West, Miranda
        Phone: (919) 684-2281
        Email: miranda.west@duke.edu
NH
  • Dartmouth Hitchcock Medical Center (Pediatric), Lebanon, NH, 03756
    Contact Information:
        Helm, Jennifer
        Phone: (603) 650-8178
        Email: Jennifer.e.helm@hitchcock.org
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
NY
  • University of Rochester Medical Center Strong Memorial (Pediatric), Rochester, NY, 14642
    Contact Information:
        Nix, Nancy
        Phone: (585) 275-8580
        Email: Nancy_Nix@URMC.Rochester.edu
OH
  • Children's Hospital Medical Center of Akron (Pediatric), Akron, OH, 44308
    Contact Information:
        Ouellette, Deborah
        Phone: (330) 543-3089
        Email: douellette@chmca.org
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
SC
  • Medical University of South Carolina (Adult), Charleston, SC, 29425
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
SD
  • Sanford Medical Center (Pediatric), Sioux Falls, SD, 57117
    Contact Information:
        Sandman, Carmen
        Phone: (605) 312-1033
        Email: Carmen.Sandman@SanfordHealth.org
TN
  • Vanderbilt Children's Hospital Vanderbilt University Medical Center (Pediatric), Nashville, TN, 37232
    Contact Information:
        Berry, Pamela
        Phone: (615) 936-8308
        Email: pamela.berry@Vanderbilt.Edu
TX
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
        Email: nxschaap@texaschildrens.org
UT
  • Intermountain Cystic Fibrosis Center (Pediatric), Salt Lake City, UT, 84132
    Contact Information:
        Vroom, Jane
        Phone: (801) 587-7458
        Email: jane.vroom@hsc.utah.edu
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