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SIMPLIFY: Study to evaluate stopping inhaled hypertonic saline or dornase alfa in people with CF who are taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (SIMPLIFY-IP-19)
This study will test the effects and safety of stopping inhaled hypertonic saline or dornase alfa (Pulmozyme®) in teens and adults with CF who are also taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (Trikafta®). Trikafta® is intended to help CFTR function closer to normal, resulting in better clearance of mucus from the lungs. Inhaled hypertonic saline and dornase alfa are intended to thin airway surface liquid and improve clearance of mucus from the lungs. They are considered to be relatively burdensome therapies, so this study will look at the impact of stopping them in people who are also taking Trikafta®.
This is an open label study, meaning all participants are taking Trikafta® and either inhaled hypertonic saline, dornase alfa, or both. There are two identical arms -- Study A and Study B. Participants in Study A will be randomly assigned to either continue or discontinue hypertonic saline. Participants in Study B will be randomly assigned to either continue or discontinue dornase alfa. Participants who are currently taking both hypertonic saline and dornase alfa will be randomized to either Study A or Study B. Researchers will test the effects of stopping inhaled hypertonic saline or dornase alfa by tracking lung function and changes in respiratory symptoms. They will also test the safety of stopping inhaled hypertonic saline or dornase alfa by monitoring for adverse events.
This study may require lung function tests and/or other measurements.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
10 weeks -
Number of Study Visits:
4
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Nichols, David -
Study Drugs:
N/A
Study Sites
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Alabama
University of Alabama at Birmingham, Birmingham, AL 35294
Contact
Heather Hathorne
Phone: +1 (205) 638-9568
Email: hhathorne@peds.uab.edu
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Alaska
Providence Alaska Medical Center, Anchorage, AK 99508
Contact
Vicki Roberts
Phone: +1 (907) 212-3299
Email: Vicki.Roberts@providence.org
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Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Monica Varela
Phone: +1 (520) 626-0462
Email: monicavarela@email.arizona.edu
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Arkansas
Arkansas Children's Hospital, Little Rock, AR 72202
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Sheila Stroupe
Phone: +1 (501) 364-2375
Email: StroupeSL@archildrens.org
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California
University of California, San Francisco, San Francisco, CA 94158
Contact
Ngoc Ly
Phone: +1 (415) 476-4979
Email: Ngoc.Ly@ucsf.edu
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California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
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Candice Evans
Phone: +1 (562) 933-5607
Email: cevans@memorialcare.org
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California
CHOC Children's Hospital, Orange, CA 92868
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Julie Nguyen Ballo
Phone: +1
Email: Julie.Nguyen@choc.org
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California
Stanford University Medical Center, Palo Alto, CA 94304
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Colleen Dunn
Phone: +1 (650) 736-0388
Email: cedunn@stanford.edu
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California
University of California, San Francisco, SF, CA 94143
Contact
Mary Ellen Kleinhenz
Phone: +1 (415) 353-4978
Email: maryellen.kleinhenz@ucsf.edu
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California
Rady Children's Hospital and Health Center at the University of California San Diego, San Diego, CA 92123
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Karl Perez
Phone: +1 (619) 471-0821
Email: kap018@ucsd.edu
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Colorado
National Jewish Health, Denver, CO 80206
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Alix Wilson
Phone: +1
Email: wilsona@njhealth.org
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Colorado
Children's Hospital Colorado, Aurora, CO 80045
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Meg Anthony
Phone: +1 (720) 777-2945
Email: Meg.Anthony@childrenscolorado.org
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Connecticut
Yale University School of Medicine, New Haven, CT 06520
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Catalina Guzman
Phone: +1 (203) 785-4971
Email: catalina.guzman@yale.edu
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Florida
University of Florida, Gainesville, FL 32610
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Phone: +1
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Florida
All Children's Hospital, St. Petersburg, FL 33701
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Diana Hodge
Phone: +1 (727) 767-6881
Email: dhodge6@jhmi.edu
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Florida
The Nemours Children's Clinic - Orlando, Orlando, FL 32827
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Amanda Darling
Phone: +1 (407) 650-7966
Email: amanda.darling@nemours.org
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Florida
Central Florida Pulmonary Group, Orlando, FL 32803
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Kenneth Kesser
Phone: +1 (407) 841-1100
Email: bkesser@cfpulmonary.com
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Florida
Tampa General Hospital, Tampa, FL 33606
Contact
Heather Glunk
Phone: +1 (813) 966-7149
Email: hglunk@health.usf.edu
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Florida
Nemours Children's Clinic - Pensacola, Pensacola, FL 32514
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Rebecca Davis
Phone: +1 (850) 473-4553
Email: Rebecca.Davis@nemours.org
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Florida
Nemours Children's Clinic, Jacksonville, FL 32207
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Jennifer (Jenn) Gafford
Phone: +1
Email: Jennifer.gafford@nemours.org
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Georgia
Emory University, Atlanta, GA 30327
Contact
Eric Hunter
Phone: +1 (404) 727-7398
Email: eahunte@emory.edu
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Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
Contact
Dixie Durham
Phone: +1 (208) 381-7334
Email: durhamd@slhs.org
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Illinois
OSF Saint Francis Medical Center, Peoria, IL 61637
Contact
Ashley Scott
Phone: +1 (309) 624-2409
Email: Ashley.Scott@osfhealthcare.org
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Illinois
Northwestern University, Chicago, IL 60611
Contact
Rachel Nelson
Phone: +1 (312) 695-0415
Email: rachel.nelson@northwestern.edu
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Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iupui.edu
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Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
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Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
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Kentucky
University of Kentucky, Lexington, KY 40506
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Christina Payne
Phone: +1 (859) 257-5087
Email: Christina.Payne@uky.edu
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Kentucky
University of Louisville, Louisville, KY 40202
Contact
Julie Burmester
Phone: +1 (502) 588-0926
Email: julie.burmester@louisville.edu
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Louisiana
Tulane University, Metairie, LA 70001
Contact
Eliza Sheffield
Phone: +1 (504) 988-7517
Email: esheffi1@tulane.edu
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Maine
Maine Medical Partners Pediatric Specialty Care, Portland, ME 04102
Contact
Carrie Milliard
Phone: +1 (207) 662-6712
Email: millic@mmc.org
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Maryland
Johns Hopkins University, Baltimore, MD 21287
Contact
Britany Zeglin
Phone: +1 (443) 287-8983
Email: bzeglin1@jhmi.edu
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Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
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Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.edu
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Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
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Michigan
Helen DeVos Children's Hospital, Grand Rapids, MI 49503
Contact
Cynthia Gile
Phone: +1 (616) 391-6148
Email: Cynthia.Gile@spectrumhealth.org
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Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
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Phone: +1
Email:
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Minnesota
The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455
Contact
Participant Contact University of Minnesota
Phone: +1
Email: cftrials@umn.edu
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Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Tina Hicks
Phone: +1 (314) 747-2707
Email: hickst@wustl.edu
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Missouri
Children's Mercy Kansas City, Kansas City, MO 64108
Contact
Candy Schmoll
Phone: +1 (816) 302-3538
Email: cschmoll@cmh.edu
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Montana
Billings Clinic , Billings, MT 59101
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Jerimiah Lysinger
Phone: +1 (406) 238-5137
Email: JLysinger@billingsclinic.org
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New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
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Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
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New Jersey
Morristown Medical Center , Morristown, NJ 07960
Contact
Nancy Martinez
Phone: +1 (973) 971-5138
Email: nancy.martinez@atlantichealth.org
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New Jersey
Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ 08903
Contact
Deborah McCloskey
Phone: +1 (732) 235-5965
Email: mcclosda@rwjms.rutgers.edu
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New Jersey
Monmouth Medical Center, Eatontown, NJ 07724
Contact
Bridget Marra
Phone: +1 (732) 222-4474
Email: bridget.marra@RWJBH.org
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New York
Columbia University Cystic Fibrosis Program, New York, NY 10032
Contact
Emily DiMango
Phone: +1 (212) 305-0290
Email: ead3@cumc.columbia.edu
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New York
Beth Israel Medical Center, New York, NY 10003
Contact
Anne Kukral
Phone: +1 (212) 420-4196
Email: anne.kukral@mountsinai.org
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New York
SUNY Upstate Medical University, Syracuse, NY 13210
Contact
Valoree Suttmore
Phone: +1 (315) 464-7593
Email: suttmorv@upstate.edu
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New York
University of Rochester Medical Center Strong Memorial, Rochester, NY 14642
Contact
Barb Johnson
Phone: +1 (585) 276-4123
Email: Barbara_Johnson@URMC.Rochester.edu
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New York
Cohen Children's Medical Center of New York, Lake Success, NY 11042
Contact
Susan Galvin
Phone: +1 (516) 321-8606
Email: sgalvin@northwell.edu
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New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
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North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, NC 27599
Contact
Kelsey Haywood
Phone: +1 (919) 445-2855
Email: kelsey_haywood@med.unc.edu
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North Carolina
Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157
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Patricia Whalen
Phone: +1 (336) 713-9190
Email: pwhalen@wakehealth.edu
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Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Sandy Bartosik
Phone: +1 (937) 641-4004
Email: bartosiks@childrensdayton.org
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Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229
Contact
Kelly Thornton
Phone: +1 (513) 636-0604
Email: Kelly.Thornton@cchmc.org
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Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
Contact
Dave Weaver
Phone: +1 (216) 445-6671
Email: weaverd@ccf.org
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Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44146
Contact
Kathleen Hilliard
Phone: +1 (216) 844-7489
Email: kathleen.hilliard@uhhospitals.org
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Ohio
Children's Hospital Medical Center of Akron, Akron, OH 44308
Contact
Brenda Bourne
Phone: +1 (330) 543-3510
Email: bbourne@akronchildrens.org
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Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
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Oregon
Oregon Health Sciences University, Portland, OR 97239
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Brendan Klein
Phone: +1 (503) 418-8108
Email: kleinb@ohsu.edu
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Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
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Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Sara Deitrick
Phone: +1 (215) 615-0276
Email: Sara.deitrick@uphs.upenn.edu
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Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
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South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
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Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75247
Contact
Daniyal Kamal
Phone: +1 (214) 456-5489
Email: Daniyal.Kamal@childrens.com
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Texas
Cook Children's Medical Center, Fort Worth, TX 76104
Contact
Heather Urbanek
Phone: +1 (682) 885-1244
Email: Heather.Urbanek@cookchildrens.org
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Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-2817
Email: Ashley.Keller@UTSouthwestern.edu
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Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
Contact
Debbie Fielder
Phone: +1 (903) 877-7753
Email: debbie.fielder@uthct.edu
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Texas
Dell Children's Medical Center of Central Texas, Austin, TX 78723
Contact
Colleen Millian
Phone: +1 (512) 380-9200
Email: CaMillian@ascension.org
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Utah
Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113
Contact
Jane Vroom
Phone: +1 (801) 587-7458
Email: jane.vroom@hsc.utah.edu
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Vermont
University of Vermont Medical Center, Burlington, VT 05401
Contact
Julie Sweet
Phone: +1 (802) 847-7958
Email: julie.sweet@uvmhealth.org
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Virginia
University of Virginia, Charlottesville, VA 22903
Contact
Christie Aderholt
Phone: +1 (434) 297-7773
Email: cla6e@virginia.edu
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Virginia
Virginia Commonwealth University, Richmond, VA 23219
Contact
Margaret (Meg) Lessard
Phone: +1 (804) 628-3093
Email: margaret.lessard@vcuhealth.org
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Washington
Seattle Children's Hospital, Seattle, WA 98105
Contact
Sharon McNamara
Phone: +1 (206) 987-3921
Email: sharon.mcnamara@seattlechildrens.org
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Washington
Providence Medical Group, Cystic Fibrosis Clinic – Pediatrics, Spokane, WA 99204
Contact
Joan Milton
Phone: +1 (509) 474-4323
Email: joan.milton@providence.org
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Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Teresa Gambol
Phone: +1 (206) 543-7382
Email: TGambol@medicine.washington.edu
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West Virginia
West Virginia University - Morgantown, Morgantown, WV 26507
Contact
Tammy Clark
Phone: +1 (304) 293-5264
Email: tclark@hsc.wvu.edu
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Wisconsin
Children's Hospital of Wisconsin, Milwaukee, WI 53226
Contact
Laura Roth
Phone: +1 (414) 266-3856
Email: lroth@mcw.edu
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Wisconsin
University of Wisconsin, Madison, WI 53792
Contact
Sophia Chiron Stevens
Phone: +1 (608) 263-1244
Email: scstevens@medicine.wisc.edu
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Wisconsin
Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226
Contact
Erin Hubertz
Phone: +1 (414) 955-7019
Email: ehubertz@mcw.edu
Related Topics
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Questions to Ask When Considering a Specific Trial
Clinical trials that test potential drugs and therapies in people with cystic fibrosis are a major part of CF research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.
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Patient Safety Is a Priority
Nothing is more important than patient safety in developing new treatments for cystic fibrosis. The U.S. government requires that all clinical trials are supervised for safety, and the Cystic Fibrosis Foundation adds additional measures to protect study volunteers.
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Trikafta™
The following is a collection of information and news about Trikafta™, the triple-combination modulator therapy that was approved by the U.S. Food and Drug Administration on Oct. 21, 2019.
