|
|
| 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looks at the ability to do exercise, pulmonary function tests and other effects in people with CF when Pulmozyme® is withdrawn for 2 weeks.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. |
| 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. |
| Sponsor Contact Information: |
Freemer, Michelle
|
| 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) 546-0343
Email: nargel@phoenixchildrens.com
|
| CA |
-
Children's Hospital of Los Angeles (Pediatric), Los Angeles, CA, 90027
Contact Information:
Ortega, Ricardo
Phone: (323) 361-6639
Email: rortega@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) 727-9960
Email: eahunte@emory.edu
-
Georgia Health Sciences 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:
Richardson, Stacey
Phone: (317) 948-7121
Email: stlyrich@iupui.edu
|
| KY |
-
University of Kentucky (Adult), Lexington, KY, 40536
Contact Information:
Watts, Tammy
Phone: (859) 257-5087
Email: twatt2@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:
Cahill, James
Phone: (313) 745-2221
Email: jcahil@med.wayne.edu
-
Spectrum Health Adult Cystic Fibrosis Care Center (Adult), Grand Rapids, MI, 49503
Contact Information:
Symington, Thomas
Phone: (616) 391-9366
Email: thomas.symington@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:
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:
Auten, Kathy
Phone: (919) 684-2281
Email: kathy.auten@duke.edu
|
| NJ |
-
Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
Marra, Bridget
Phone: (732) 222-4474
Email: bmarra@sbhcs.com
-
Goryeb Children's Hospital of Atlantic Health (Adult), Morristown, NJ, 07962
Contact Information:
Cahill, Carol
Phone: (973) 971-5138
Email: carol.cahill@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
|
| TX |
-
Christus Santa Rose Children's Hospital (Adult), San Antonio, TX, 78212
Contact Information:
Phillips, Teresa
Phone: (210) 223-3010
Email: tphillips@acra-sa.com
|
| 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
|
|
