Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study

NACompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

August 25, 2020

Primary Completion Date

July 11, 2022

Study Completion Date

July 11, 2022

Conditions
Cystic Fibrosis
Interventions
OTHER

Discontinuation of hypertonic saline (HS)

Discontinuation of current hypertonic saline (HS) therapy during 6-week study period.

OTHER

Continuation of hypertonic saline (HS)

Continuation of current hypertonic saline (HS) therapy during 6-week study period. Therapy is taken at least once daily according to each participant's pre-existing, clinically prescribed regimen (e.g., daily, twice daily). The concentration of HS is according to clinical prescription (e.g., 7% sodium chloride or 3.5% sodium chloride) and at least 3%.

Trial Locations (81)

10003

Beth Israel Medical Center, New York

10028

Lenox Hill Hospital Cystic Fibrosis Center, New York

10032

Columbia University Cystic Fibrosis Program, New York

10595

New York Medical College at Westchester Medical Center, Valhalla

11042

Cohen Children's Medical Center of New York, New Hyde Park

13210

SUNY Upstate Medical University, Syracuse

14642

University of Rochester Medical Center Strong Memorial, Rochester

15224

University of Pittsburgh Medical Center, Pittsburgh

17033

Hershey Medical Center Pennsylvania State University, Hershey

19104

University of Pennsylvania, Philadelphia

21287

Johns Hopkins University, Baltimore

22904

University of Virginia, Charlottesville

23219

Virginia Commonwealth University, Richmond

26506

West Virginia University - Morgantown, Morgantown

27157

Atrium Health Wake Forest Baptist, Winston-Salem

27517

University of North Carolina at Chapel Hill, Chapel Hill

29425

Medical University of South Carolina, Charleston

30324

Emory University, Atlanta

32207

Nemours Children's Clinic - Jacksonville, Jacksonville

32514

Nemours Children's Clinic - Pensacola, Pensacola

32610

University of Florida, Gainesville

32803

Central Florida Pulmonary Group, Orlando

32827

The Nemours Children's Clinic - Orlando, Orlando

33606

Tampa General Hospital, Tampa

33701

All Children's Hospital, St. Petersburg

35294

University of Alabama at Birmingham, Birmingham

40202

University of Louisville, Louisville

40506

University of Kentucky, Lexington

43205

Nationwide Children's Hospital, Columbus

44146

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic Cystic Fibrosis Program, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

Dayton Children's Hospital, Dayton

46202

Riley Hospital for Children, Indianapolis

48109

University of Michigan, Michigan Medicine, Ann Arbor

48201

Wayne State University Harper University Hospital, Detroit

49546

Corewell Health Helen DeVos, Grand Rapids

52242

University of Iowa, Iowa City

53226

Children's Wisconsin, Milwaukee

Froedtert & Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin, Madison

55404

Children's Hospitals and Clinics of Minnesota, Minneapolis

55455

The Minnesota Cystic Fibrosis Center, Minneapolis

59101

Billings Clinic, Billings

60611

Northwestern University, Chicago

61637

OSF Saint Francis Medical Center, Peoria

63110

Washington University School of Medicine, St Louis

64108

Children's Mercy Kansas City, Kansas City

66160

University of Kansas Medical Center, Kansas City

70001

Tulane University, Metairie

72202

Arkansas Children's Hospital, Little Rock

75207

University of Texas Southwestern / Children's Health, Dallas

75390

University of Texas Southwestern, Dallas

75708

University of Texas Health Center at Tyler, Tyler

76104

Cook Children's Medical Center, Fort Worth

78723

Dell Children's Medical Center of Central Texas, Austin

80045

Children's Hospital Colorado, Aurora

80206

National Jewish Health, Denver

83702

Saint Luke's Cystic Fibrosis Center of Idaho, Boise

84113

Primary Children's Cystic Fibrosis Center, Salt Lake City

85724

Tucson Cystic Fibrosis Center, Tucson

90806

Miller Children's and Women's Hospital Long Beach, Long Beach

92123

Rady Children's Hospital and Health Center at the University of California San Diego, San Diego

92868

CHOC Children's Hospital, Orange

94143

University of California, San Francisco - Adult Center, San Francisco

94158

University of California, San Francisco - Peds Center, San Francisco

94304

Stanford University Medical Center, Palo Alto

97239

Oregon Health & Sciences University, Portland

98105

Seattle Children's Hospital, Seattle

98195

University of Washington Medical Center, Seattle

99204

Providence Medical Group, Cystic Fibrosis Clinic, Spokane

99508

Providence Alaska Medical Center, Anchorage

06520

Yale University School of Medicine, New Haven

04102

Maine Medical Partners Pediatric Specialty Care, Portland

02115

Boston Children's Hospital, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

07724

Monmouth Medical Center, Eatontown

07960

Morristown Medical Center, Morristown

08903

Rutgers - Robert Wood Johnson Medical School, New Brunswick

05401

University of Vermont Medical Center, Burlington

All Listed Sponsors
collaborator

Cystic Fibrosis Foundation

OTHER

collaborator

Dartmouth-Hitchcock Medical Center

OTHER

collaborator

University of Washington

OTHER

lead

Nicole Hamblett

OTHER

NCT06350461 - Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study | Biotech Hunter | Biotech Hunter