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Study Name: Effect of Pulmozyme® Withdrawal on Exercise Tolerance in People with Cystic Fibrosis
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: 100
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study looks at the ability to do exercise, pulmonary function tests and other effects in people with CF when Pulmozyme® is withdrawn for 2 weeks. Pulmozyme® is an approved drug that thins mucus in the lungs of people with CF, making it easier to cough out the mucus. People whose CF symptoms are stable for 2 weeks prior to joining the trial will be able to participate. The study will last at most 35 days with four study visits. The exercise will be a 6-minute walk test on a flat surface. Outcome measures will also be pulmonary function; patient-reported health-related quality of life questions (HRQOL); and other measures.
ELIGIBILITY
Age: >= 14 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

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: Freemer, Michelle
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct/show/NCT00434278?order=6
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.
AL
  • University of Alabama at Birmingham (Adult), Birmingham, AL, 35294
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
AZ
  • Phoenix Children's Hospital (Adult), Phoenix, AZ, 85016
    Contact Information:
        Argel, Natalia
        Phone: (602) 933-0343
        Email: Nargel@phoenixchildrens.com
CA
  • Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
    Contact Information:
        Vajda, Natalie
        Phone: (323) 361-3255
        Email: nvajda@chla.usc.edu
  • USC Keck School of Medicine (Adult), Los Angeles, CA, 90033
    Contact Information:
        Fukushima, Lynn
        Phone: (323) 442-5869
        Email: lynn.fukushima@med.usc.edu
CO
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
FL
  • University of Miami (Adult), Miami, FL, 33136
    Contact Information:
        Mendes, Eliana
        Phone: (305) 243-2568
        Email: emendes@med.miami.edu
GA
  • Emory University (Adult), Atlanta, GA, 30322
    Contact Information:
        Hunter, Eric
        Phone: (404) 785-3102
        Email: eahunte@emory.edu
  • Georgia Regents University (Pediatric), Augusta, GA, 30912
    Contact Information:
        Stapp, Heidi
        Phone: (706) 721-7699
        Email: hstapp@gru.edu
IL
  • Rush University Medical Center (Pediatric), Chicago, IL, 60612
    Contact Information:
        Burke, Jenifer
        Phone: (312) 563-2273
        Email: Jenifer_Burke@rush.edu
IN
  • Indiana University (Adult), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
KY
  • University of Kentucky (Adult), Lexington, KY, 40536
    Contact Information:
        Watts, Tammy
        Phone: (859) 257-5087
        Email: Tammy.watts@uky.edu
MI
  • University of Michigan Health System (Adult), Ann Arbor, MI, 48109
    Contact Information:
        Kruse, Dawn
        Phone: (734) 615-3266
        Email: dmkruse@umich.edu
  • Wayne State University Harper University Hospital (Adult), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
  • Spectrum Health Adult Cystic Fibrosis Care Center (Adult), Grand Rapids, MI, 49503
    Contact Information:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
MN
  • The Minnesota Cystic Fibrosis Center (Adult), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
MO
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Hicks, Tina
        Phone: (314) 747-2707
        Email: Hicks_T@kids.wustl.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Rodgers, Denise
        Phone: (314) 286-1176
        Email: rodgers@kids.wustl.edu
  • St. Louis Children's Hospital Washington University (Pediatric), St. Louis, MO, 63110
    Contact Information:
        Burks, Patricia
        Phone: (314) 454-5175
        Email: Burks_P@kids.wustl.edu
MS
  • University of Mississippi Medical Center (Adult), Jackson, MS, 39216
    Contact Information:
        Adcock, Kim
        Phone: (601) 815-9172
        Email: kadcock@umc.edu
NC
  • Duke University Medical Center (Pediatric), Durham, NC, 27710
    Contact Information:
        West, Miranda
        Phone: (919) 684-2281
        Email: miranda.west@duke.edu
NJ
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
        Email: bmarra@barnabashealth.org
  • Morristown Medical Center (Adult), Morristown, NJ, 07962
    Contact Information:
        Martinez, Nancy
        Phone: (973) 971-5138
        Email: nancy.martinez@atlantichealth.org
NM
  • University of New Mexico School of Medicine (Adult), Albuquerque, NM, 87131
    Contact Information:
        Redway, Abby
        Phone: (505) 272-5886
        Email: ajredway@salud.unm.edu
NY
  • Albany Medical College (Adult), Albany, NY, 12208
    Contact Information:
        Mokhiber, Katharine
        Phone: (518) 262-6608
        Email: mokhibk@mail.amc.edu
  • Long Island Jewish Medical Center Adult Program (Adult), New Hyde Park, NY, 11040
    Contact Information:
        Wann, Li-Chen
        Phone: (516) 712-9608
        Email: LCWann@nshs.edu
  • SUNY Upstate Medical University (Adult), Syracuse, NY, 13210
    Contact Information:
        Lindner, Donna
        Phone: (315) 464-7525
        Email: lindnerd@upstate.edu
OH
  • 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
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
        Email: kelly.houser@promedica.org
PA
  • University of Pittsburgh School of Medicine (Adult), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
WV
  • West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
    Contact Information:
        Collins, Sue
        Phone: (304) 293-7348
        Email: scollins@hsc.wvu.edu
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