|
|
| Study Name: |
Denufosol (TIGER 2) Open Label Follow On |
| Study Type: |
Interventional |
| Intervention Category: |
Restore Airway Surface Liquid |
| Study Sponsor: |
Inspire |
| Study Phase: |
4 |
| Recruitment Status: |
Trial Completed |
| Study Drug(s): |
Denufosol |
| Number of Participants Being Recruited: |
385 |
| Single / Multi-Center: |
Multi-Center |
| STUDY BACKGROUND INFORMATION: |
| This study will obtain data on the long term safety of Denufosol in patients with CF. It will also evaluate the potential for long-term treatment with denufosol to maintain or improve lung function in patients with mild CF lung disease. |
| Age: |
>= 5 Years
|
| FEV1: |
Not Applicable
|
| P. aeruginosa status: |
Not applicable |
| B. cepacia status: |
Not applicable |
Other Primary Eligibility Requirements:
To be eligible for this open-label extension study, a subject must have completed TIGER 2.
|
| 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: |
Herje, Nancy
(919) 287-1209
nherje@inspirepharm.com
|
| 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. |
| AK |
-
Providence Alaska Medical Center (Pediatric and Adult), Anchorage, AK, 99508
Contact Information:
Roberts, Vicki
Phone: (907) 212-3299
Email: vicki.roberts@providence.org
|
| AL |
-
The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
Contact Information:
Hathorne, Heather
Phone: (205) 638-9568
Email: hhathorne@peds.uab.edu
|
| AZ |
-
Phoenix Children's Hospital (Pediatric), Phoenix, AZ, 85016
Contact Information:
Argel, Natalia
Phone: (602) 546-0343
Email: nargel@phoenixchildrens.com
-
Tucson CF Center (Pediatric and Adult), Tucson, AZ, 85724
Contact Information:
Molina, Osmara
Phone: (520) 891-6767
Email: omolina@arc.arizona.edu
|
| 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
-
Kaiser Permanente Medical Care Program (Pediatric), Oakland, CA, 94611
Contact Information:
Lee, Julie
Phone: (510) 752-7558
Email: julie.lee@kp.org
-
Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
Contact Information:
Dunn, Colleen
Phone: (650) 736-0388
Email: cedunn@stanford.edu
-
Rady Children's Hospital San Diego and Health Center at the University of California San Diego (Pediatric), San Diego, CA, 92123
Contact Information:
Holland, Sarah
Phone: (858) 966-8153
Email: sholland@rchsd.org
|
| CO |
|
|
| DE |
-
Alfred I. duPont Hospital for Children (Pediatric and Adult), Wilmington, DE, 19899
Contact Information:
Budd, Sandra
Phone: (302) 651-6536
Email: sbudd@nemours.org
|
| FL |
-
Nemours Children's Clinic - Jacksonville (Pediatric), Jacksonville, FL, 32207
Contact Information:
DeLuca, Elizabeth
Phone: (904) 697-3804
Email: bdeluca@nemours.org
-
All Children's Hospital (Pediatric), St. Petersburg, FL, 33701
Contact Information:
Hosler, Kathy
Phone: (727) 767-7247
Email: Kathy.Hosler@allkids.org
-
Tampa General Hospital (Adult), Tampa, FL, 33606
Contact Information:
Roberson, Suzanne
Phone: (813) 844-7179
Email: sroberson@tgh.org
|
| GA |
-
Emory University (Pediatric), Atlanta, GA, 30322
Contact Information:
Hunter, Eric
Phone: (404) 727-9960
Email: eahunte@emory.edu
|
| IL |
-
Ann and Robert H. Lurie Children's Hospital of Chicago (Pediatric), Chicago, IL, 60611
Contact Information:
Singh, Noopur
Phone: (312) 227-6861
Email: nosingh@luriechildrens.org
|
| IN |
-
Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
Contact Information:
Richardson, Stacey
Phone: (317) 948-7121
Email: stlyrich@iupui.edu
|
| KS |
-
Via Christi - Saint Francis Campus (Pediatric), Wichita, KS, 67218
Contact Information:
Miller, Sheri
Phone: (316) 268-6028
Email: Sheri.Miller@viachristi.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
|
| MD |
-
Johns Hopkins University (Pediatric), Baltimore, MD, 21287
Contact Information:
Callahan, Karen
Phone: (443) 287-8983
Email: kcallah1@jhmi.edu
|
| ME |
-
Maine Medical Partners Pediatric Specialty Care (Pediatric), Portland, ME, 04102
Contact Information:
Milliard, Carrie
Phone: (207) 662-6712
Email: millic@mmc.org
|
| MI |
-
University of Michigan Health System (Pediatric), Ann Arbor, MI, 48109
Contact Information:
Kruse, Dawn
Phone: (734) 615-3266
Email: dmkruse@umich.edu
-
Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
Contact Information:
Symington, Thomas
Phone: (616) 391-9366
Email: thomas.symington@spectrumhealth.org
|
| MN |
-
Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
Contact Information:
Johnson, Mahrya
Phone: (612) 813-6384
Email: mahrya.johnson@childrensmn.org
-
The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
Contact Information:
Grover, Patricia
Phone: (612) 626-7425
Email: Grove026@umn.edu
|
| MO |
-
The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
Contact Information:
Schmoll, Candy
Phone: (816) 701-1339
Email: cschmoll@cmh.edu
-
Cardinal Glennon Children's Medical Center (St. Louis University) (Pediatric), St. Louis, MO, 63104
Contact Information:
Kociela, Vikki
Phone: (314) 577-5608
Email: kocielav@slu.edu
|
| NC |
-
Duke University Medical Center (Pediatric), Durham, NC, 27710
Contact Information:
Auten, Kathy
Phone: (919) 684-2281
Email: kathy.auten@duke.edu
|
| NE |
-
University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
Telfer, Raquel
Phone: (402) 559-6275
Email: raquel.telfer@unmc.edu
-
University of Nebraska Medical Center (Pediatric), Omaha, NE, 68198
Contact Information:
Acquazzino, Diane
Phone: (402) 559-6275
Email: dracquaz@unmc.edu
|
| NJ |
-
Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
Contact Information:
Marra, Bridget
Phone: (732) 222-4474
Email: bmarra@sbhcs.com
|
| NY |
-
Albany Medical College (Adult), Albany, NY, 12208
Contact Information:
Mokhiber, Katharine
Phone: (518) 262-6608
Email: mokhibk@mail.amc.edu
-
Albany Medical College (Pediatric), Albany, NY, 12208
Contact Information:
Evans, Terese
Phone: (518) 262-5293
Email: evansmt@mail.amc.edu
-
Beth Israel Medical Center (Pediatric), New York, NY, 10003
Contact Information:
Grece, Carroll Anne
Phone: (212) 420-4196
Email: cgrece@chpnet.org
-
Columbia University, Adult Cystic Fibrosis Program (Adult), New York City, NY, 10032
Contact Information:
Robinson, Victoria
Phone: (212) 305-0686
Email: vgr2103@columbia.edu
-
SUNY Upstate Medical University (Pediatric), Syracuse, NY, 13210
Contact Information:
Lindner, Donna
Phone: (315) 464-7525
Email: lindnerd@upstate.edu
-
New York Medical College/Westchester Medical Center (Pediatric), Valhalla, NY, 10595
Contact Information:
Gherson, Ingrid
Phone: (914) 594-3320
Email: ingrid_gherson@nymc.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
-
Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
Contact Information:
Duan, Lorrie
Phone: (513) 636-7089
Email: lorrie.duan@cchmc.org
-
Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
Contact Information:
Johnson, Mary Terri
Phone: (614) 722-4766
Email: Terri.Johnson@nationwidechildrens.org
-
The Children's Medical Center of Dayton (Pediatric), Dayton, OH, 45404
Contact Information:
Bartosik, Sandy
Phone: (937) 641-4004
Email: bartosiks@childrensdayton.org
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Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
Contact Information:
Houser, Kelly
Phone: (419) 291-4630
Email: kelly.houser@promedica.org
|
| OR |
-
Oregon Health Sciences University (Pediatric), Portland, OR, 97201
Contact Information:
Andrews-Chavez, Brian
Phone: (503) 494-6974
Email: andrewbr@ohsu.edu
|
| PA |
-
Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
Contact Information:
Kitch, Diane
Phone: (717) 531-5646
Email: dkitch@psu.edu
-
Children's Hospital of Philadelphia University of Pennsylvania (Pediatric), Philadelphia, PA, 19104
Contact Information:
Kubrak, Christina
Phone: (267) 426-5135
Email: kubrak@email.chop.edu
|
| SC |
-
Medical University of South Carolina (Pediatric), Charleston, SC, 29403
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
|
| TX |
-
Dell Children's Medical Center of Central Texas (Pediatric and Adult), Austin, TX, 78723
Contact Information:
Brazil, Isolde
Phone: (512) 380-9200 X206
Email: IBrazil@accapa.com
-
Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
Contact Information:
Hebert, Andrew
Phone: (214) 456-5618
Email: andrew.hebert@childrens.com
-
Children's Medical Center of Dallas (Pediatric), Dallas, TX, 75235
Contact Information:
Dunn-Richmond, Kate
Phone: (214) 648-2817
Email: Kate.dunn-richmond@utsouthwestern.edu
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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
|
| VA |
-
University of Virginia (Pediatric), Charlottesville, VA, 22908
Contact Information:
Moss, Patricia
Phone: (434) 243-2876
Email: pcm2v@virginia.edu
-
Children's Hospital of the King's Daughters (Pediatric), Norfolk, VA, 23507
Contact Information:
Perkins, Susan
Phone: (757) 668-6416
Email: PerkinSR@evms.edu
-
Virginia Commonwealth University (Pediatric), Richmond, VA, 23235
Contact Information:
Ward, Matthew
Phone: (804) 628-3093
Email: wardmt@vcu.edu
|
| WI |
-
University of Wisconsin (Pediatric), Madison, WI, 53792
Contact Information:
Makholm, Linda
Phone: (608) 262-0340
Email: Lmakholm@uwhealth.org
|
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