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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.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
60% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must be currently receiving elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to the screening visit and willing to continue during the study. They must also be currently taking hypertonic saline (at least 3 percent) and/or dornase alfa for at least 90 days prior to and including the screening visit and willing to continue during the study. FEV1 percent predicted at the screening visit must be at least 70 percent predicted if the participant is under 18 years old, and at least 60 percent predicted at the screening visit if the participant is 18 years old or older.
Study Design
-
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
-
Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Nichols, David -
Study Drugs:
N/A
Study Sites
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Enrolling
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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Enrolling
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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Enrolling
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Phone: +1
Email:
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Enrolling
Arkansas
Arkansas Children's Hospital, Little Rock, AR 72202
Contact
Sheila Stroupe
Phone: +1 (501) 364-2375
Email: StroupeSL@archildrens.org
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Enrolling
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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Enrolling
California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
Contact
Candice Evans
Phone: +1 (562) 933-5607
Email: cevans@memorialcare.org
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Enrolling
California
CHOC Children's Hospital, Orange, CA 92868
Contact
Yvonne Chase
Phone: +1 (714) 509-8810
Email: YChase@choc.org
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California
Stanford University Medical Center, Palo Alto, CA 94304
Contact
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
Contact
Phone: +1
Email:
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Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2333
Email: wilsona@njhealth.org
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Enrolling
Colorado
Children's Hospital Colorado, Aurora, CO 80045
Contact
Meg Anthony
Phone: +1 (720) 777-2945
Email: Meg.Anthony@childrenscolorado.org
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Enrolling
Connecticut
Yale University School of Medicine, New Haven, CT 06520
Contact
Catalina Guzman
Phone: +1 (203) 785-4971
Email: catalina.guzman@yale.edu
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Florida
University of Florida, Gainesville, FL 32610
Contact
Phone: +1
Email:
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Florida
All Children's Hospital, St. Petersburg, FL 33701
Contact
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
Contact
Amanda Darling
Phone: +1 (407) 650-7966
Email: amanda.darling@nemours.org
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Enrolling
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kenneth Kesser
Phone: +1 (407) 841-1100
Email: bkesser@cfpulmonary.com
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Enrolling Soon
Florida
Tampa General Hospital, Tampa, FL 33606
Contact
Kristen Grube
Phone: +1 (813) 844-8624
Email: klgrube@usf.edu
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Enrolling
Florida
Nemours Children's Clinic - Pensacola, Pensacola, FL 32514
Contact
Rebecca Davis
Phone: +1 (850) 473-4553
Email: Rebecca.Davis@nemours.org
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Enrolling
Florida
Nemours Children's Clinic, Jacksonville, FL 32207
Contact
Jennifer (Jenn) Gafford
Phone: +1 (904) 697-3600
Email: Jennifer.gafford@nemours.org
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Enrolling
Georgia
Emory University, Atlanta, GA 30327
Contact
Eric Hunter
Phone: +1 (404) 727-7398
Email: eahunte@emory.edu
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Enrolling
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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Enrolling
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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Enrolling
Illinois
Northwestern University, Chicago, IL 60611
Contact
Rachel Nelson
Phone: +1 (312) 695-0415
Email: rachel.nelson@northwestern.edu
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Enrolling
Indiana
Riley Hospital for Children, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.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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Enrolling
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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Enrolling
Kentucky
University of Kentucky, Lexington, KY 40506
Contact
Christina Payne
Phone: +1 (859) 257-5087
Email: Christina.Payne@uky.edu
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Enrolling
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Julie Burmester
Phone: +1 (502) 588-0926
Email: julie.burmester@louisville.edu
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Enrolling
Louisiana
Tulane University, Metairie, LA 70001
Contact
Nicole Falgout
Phone: +1 (504) 988-2566
Email: nfalgout@tulane.edu
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Enrolling
Maine
Maine Medical Partners Pediatric Specialty Care, Portland, ME 04102
Contact
Harmony Renna
Phone: +1 (207) 662-5917
Email: rennah@mmc.org
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Enrolling
Maryland
Johns Hopkins University, Baltimore, MD 21287
Contact
Britany Zeglin
Phone: +1 (443) 287-8983
Email: bzeglin1@jhmi.edu
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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
Michigan
Helen DeVos Children's Hospital, Grand Rapids , MI 49503
Contact
Heather Mulroy
Phone: +1 (616) 391-0384
Email: heather.mulroy@spectrumhealth.org
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Enrolling
Minnesota
Children’s Hospitals and Clinics of Minnesota, Minneapolis, MN 55404
Contact
Camerone Bey
Phone: +1 (612) 813-7628
Email: Camerone.bey@childrensmn.org
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Enrolling
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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Enrolling
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, KCMO, MO 64108
Contact
Candy Schmoll
Phone: +1 (816) 302-3538
Email: cschmoll@cmh.edu
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Enrolling
Montana
Billings Clinic , Billings, MT 59101
Contact
Jerimiah Lysinger
Phone: +1 (406) 238-5137
Email: JLysinger@billingsclinic.org
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Enrolling
New Hampshire
Dartmouth Hitchcock Medical Center, Lebanon, NH 03756
Contact
Barbara Rodgers
Phone: +1 (603) 650-9718
Email: Barbara.A.Rodgers@hitchcock.org
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Enrolling
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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Enrolling Soon
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
New York
SUNY Upstate Medical University, Syracuse, NY 13210
Contact
Mary Forell
Phone: +1 (315) 464-9209
Email: forellm@upstate.edu
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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, NC 27599
Contact
Ashley Synger
Phone: +1
Email: ashley_synger@med.unc.edu
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Enrolling
North Carolina
Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157
Contact
Patricia Whalen
Phone: +1 (336) 713-9190
Email: pwhalen@wakehealth.edu
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Enrolling
Ohio
Dayton Children's Hospital, Dayton, OH 45404
Contact
Sandy Bartosik
Phone: +1 (937) 641-4004
Email: bartosiks@childrensdayton.org
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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
Oregon
Oregon Health Sciences University, Portland, OR 97239
Contact
Brendan Klein
Phone: +1 (503) 418-8108
Email: kleinb@ohsu.edu
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Enrolling
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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Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
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Enrolling
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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Enrolling
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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Enrolling
Texas
University of Texas Southwestern / Children’s Health, Dallas, TX 75207
Contact
Daniyal Kamal
Phone: +1 (214) 456-5489
Email: Daniyal.Kamal@childrens.com
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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
Virginia
University of Virginia, Charlottesville, VA 22903
Contact
Theresa Altherr
Phone: +1
Email: taa4n@virginia.edu
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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
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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Enrolling
Wisconsin
Froedtert & Medical College of Wisconsin, Milwaukee, WI 53226
Contact
Erin Hubertz
Phone: +1 (414) 955-7019
Email: ehubertz@mcw.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
60% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Eligible participants must be currently receiving elexacaftor/tezacaftor/ivacaftor for at least 90 days prior to the screening visit and willing to continue during the study. They must also be currently taking hypertonic saline (at least 3 percent) and/or dornase alfa for at least 90 days prior to and including the screening visit and willing to continue during the study. FEV1 percent predicted at the screening visit must be at least 70 percent predicted if the participant is under 18 years old, and at least 60 percent predicted at the screening visit if the participant is 18 years old or older.
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.
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