protocolSection identificationModule nctId: NCT06350461, orgStudyIdInfo id: SIMPLIFY-IP-19 HS, briefTitle: Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study, acronym: SIMPLIFY-HS, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-25, primaryCompletionDateStruct date: 2022-07-11, completionDateStruct date: 2022-07-11, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Nicole Hamblett, class: OTHER, collaborators name: Cystic Fibrosis Foundation, collaborators name: Dartmouth-Hitchcock Medical Center, collaborators name: University of Washington, descriptionModule briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available)., conditionsModule conditions: Cystic Fibrosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 370, type: ACTUAL, armsInterventionsModule interventions name: Discontinuation of hypertonic saline (HS), interventions name: Continuation of hypertonic saline (HS), outcomesModule primaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in LCI 2.5 From Baseline to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0, secondaryOutcomes measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2, secondaryOutcomes measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6, secondaryOutcomes measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6, secondaryOutcomes measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6, secondaryOutcomes measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms, secondaryOutcomes measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Providence Alaska Medical Center, city: Anchorage, state: Alaska, zip: 99508, country: United States, geoPoint lat: 61.21806, lon: -149.90028, locations facility: Tucson Cystic Fibrosis Center, city: Tucson, state: Arizona, zip: 85724, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Arkansas Children's Hospital, city: Little Rock, state: Arkansas, zip: 72202, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Miller Children's and Women's Hospital Long Beach, city: Long Beach, state: California, zip: 90806, country: United States, geoPoint lat: 33.76696, lon: -118.18923, locations facility: CHOC Children's Hospital, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: Stanford University Medical Center, city: Palo Alto, state: California, zip: 94304, country: United States, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Rady Children's Hospital and Health Center at the University of California San Diego, city: San Diego, state: California, zip: 92123, country: United States, geoPoint lat: 32.71533, lon: -117.15726, locations facility: University of California, San Francisco - Adult Center, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of California, San Francisco - Peds Center, city: San Francisco, state: California, zip: 94158, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Children's Hospital Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: Yale University School of Medicine, city: New Haven, state: Connecticut, zip: 06520, country: United States, geoPoint lat: 41.30815, lon: -72.92816, locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Nemours Children's Clinic - Jacksonville, city: Jacksonville, state: Florida, zip: 32207, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Central Florida Pulmonary Group, city: Orlando, state: Florida, zip: 32803, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: The Nemours Children's Clinic - Orlando, city: Orlando, state: Florida, zip: 32827, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Nemours Children's Clinic - Pensacola, city: Pensacola, state: Florida, zip: 32514, country: United States, geoPoint lat: 30.42131, lon: -87.21691, locations facility: All Children's Hospital, city: Saint Petersburg, state: Florida, zip: 33701, country: United States, geoPoint lat: 27.77086, lon: -82.67927, locations facility: Tampa General Hospital, city: Tampa, state: Florida, zip: 33606, country: United States, geoPoint lat: 27.94752, lon: -82.45843, locations facility: Emory University, city: Atlanta, state: Georgia, zip: 30324, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Saint Luke's Cystic Fibrosis Center of Idaho, city: Boise, state: Idaho, zip: 83702, country: United States, geoPoint lat: 43.6135, lon: -116.20345, locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, geoPoint lat: 41.85003, lon: -87.65005, locations facility: OSF Saint Francis Medical Center, city: Peoria, state: Illinois, zip: 61637, country: United States, geoPoint lat: 40.69365, lon: -89.58899, locations facility: Riley Hospital for Children, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: University of Iowa, city: Iowa City, state: Iowa, zip: 52242, country: United States, geoPoint lat: 41.66113, lon: -91.53017, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40506, country: United States, geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Louisville, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Tulane University, city: Metairie, state: Louisiana, zip: 70001, country: United States, geoPoint lat: 29.98409, lon: -90.15285, locations facility: Maine Medical Partners Pediatric Specialty Care, city: Portland, state: Maine, zip: 04102, country: United States, geoPoint lat: 43.66147, lon: -70.25533, locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Michigan, Michigan Medicine, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Wayne State University Harper University Hospital, city: Detroit, state: Michigan, zip: 48201, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: Corewell Health Helen DeVos, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: Children's Hospitals and Clinics of Minnesota, city: Minneapolis, state: Minnesota, zip: 55404, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: The Minnesota Cystic Fibrosis Center, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Children's Mercy Kansas City, city: Kansas City, state: Missouri, zip: 64108, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Billings Clinic, city: Billings, state: Montana, zip: 59101, country: United States, geoPoint lat: 45.78329, lon: -108.50069, locations facility: Dartmouth Hitchcock Medical Center, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, geoPoint lat: 43.64229, lon: -72.25176, locations facility: Monmouth Medical Center, city: Eatontown, state: New Jersey, zip: 07724, country: United States, geoPoint lat: 40.29622, lon: -74.05097, locations facility: Morristown Medical Center, city: Morristown, state: New Jersey, zip: 07960, country: United States, geoPoint lat: 40.79677, lon: -74.48154, locations facility: Rutgers - Robert Wood Johnson Medical School, city: New Brunswick, state: New Jersey, zip: 08903, country: United States, geoPoint lat: 40.48622, lon: -74.45182, locations facility: Cohen Children's Medical Center of New York, city: New Hyde Park, state: New York, zip: 11042, country: United States, geoPoint lat: 40.7351, lon: -73.68791, locations facility: Beth Israel Medical Center, city: New York, state: New York, zip: 10003, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Lenox Hill Hospital Cystic Fibrosis Center, city: New York, state: New York, zip: 10028, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Columbia University Cystic Fibrosis Program, city: New York, state: New York, zip: 10032, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: University of Rochester Medical Center Strong Memorial, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, locations facility: SUNY Upstate Medical University, city: Syracuse, state: New York, zip: 13210, country: United States, geoPoint lat: 43.04812, lon: -76.14742, locations facility: New York Medical College at Westchester Medical Center, city: Valhalla, state: New York, zip: 10595, country: United States, geoPoint lat: 41.07482, lon: -73.77513, locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Atrium Health Wake Forest Baptist, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, geoPoint lat: 36.09986, lon: -80.24422, locations facility: Children's Hospital Medical Center of Akron, city: Akron, state: Ohio, zip: 44308, country: United States, geoPoint lat: 41.08144, lon: -81.51901, locations facility: Cincinnati Children's Hospital Medical Center, city: Cincinnati, state: Ohio, zip: 45229, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, city: Cleveland, state: Ohio, zip: 44146, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Cleveland Clinic Cystic Fibrosis Program, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Nationwide Children's Hospital, city: Columbus, state: Ohio, zip: 43205, country: United States, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Dayton Children's Hospital, city: Dayton, state: Ohio, zip: 45404, country: United States, geoPoint lat: 39.75895, lon: -84.19161, locations facility: Oregon Health & Sciences University, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Hershey Medical Center Pennsylvania State University, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, geoPoint lat: 40.28592, lon: -76.65025, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Medical University of South Carolina, city: Charleston, state: South Carolina, zip: 29425, country: United States, geoPoint lat: 32.77657, lon: -79.93092, locations facility: Dell Children's Medical Center of Central Texas, city: Austin, state: Texas, zip: 78723, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: University of Texas Southwestern / Children's Health, city: Dallas, state: Texas, zip: 75207, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: University of Texas Southwestern, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Cook Children's Medical Center, city: Fort Worth, state: Texas, zip: 76104, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: University of Texas Health Center at Tyler, city: Tyler, state: Texas, zip: 75708, country: United States, geoPoint lat: 32.35126, lon: -95.30106, locations facility: Primary Children's Cystic Fibrosis Center, city: Salt Lake City, state: Utah, zip: 84113, country: United States, geoPoint lat: 40.76078, lon: -111.89105, locations facility: University of Vermont Medical Center, city: Burlington, state: Vermont, zip: 05401, country: United States, geoPoint lat: 44.47588, lon: -73.21207, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22904, country: United States, geoPoint lat: 38.02931, lon: -78.47668, locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23219, country: United States, geoPoint lat: 37.55376, lon: -77.46026, locations facility: Seattle Children's Hospital, city: Seattle, state: Washington, zip: 98105, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: University of Washington Medical Center, city: Seattle, state: Washington, zip: 98195, country: United States, geoPoint lat: 47.60621, lon: -122.33207, locations facility: Providence Medical Group, Cystic Fibrosis Clinic, city: Spokane, state: Washington, zip: 99204, country: United States, geoPoint lat: 47.65966, lon: -117.42908, locations facility: West Virginia University - Morgantown, city: Morgantown, state: West Virginia, zip: 26506, country: United States, geoPoint lat: 39.62953, lon: -79.9559, locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, locations facility: Children's Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, locations facility: Froedtert & Medical College of Wisconsin, city: Milwaukee, state: Wisconsin, zip: 53226, country: United States, geoPoint lat: 43.0389, lon: -87.90647, hasResults: False