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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: |
Recruiting |
| 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. |
| 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. |
| Sponsor Contact Information: |
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| 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 |
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Arkansas Children's Hospital (Pediatric), Little Rock, AR, 72202
Contact Information:
Hart, Michelle
Phone: (501) 364-4490
Email: HartM@archildrens.org
|
| MA |
-
Children's Hospital Boston (Pediatric), Boston, MA, 02115
Contact Information:
Leone Thakkallapalli, Erin
Phone: (617) 355-3197
Email: erin.leone@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
|
| NH |
-
Dartmouth Hitchcock Medical Center (Adult), Lebanon, NH, 03756
Contact Information:
Moulton, Lisa
Phone: (603) 650-8178
Email: Lisa.A.Moulton@Hitchcock.ORG
|
| NJ |
-
Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
Marra, Bridget
Phone: (732) 222-4474
Email: bmarra@sbhcs.com
|
| NY |
-
University of Rochester Medical Center Strong Memorial (Pediatric), Rochester, NY, 14642
Contact Information:
Jenks, Nancy
Phone: (585) 275-8580
Email: nancy_jenks@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
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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:
Hanson, Dawn
Phone: (605) 312-1033
Email: Dawn.Hanson@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
|
| 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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