[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nicole Hamblett\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100646155","rethinking-early-airway-clearence-therapies-100646155",false,"NCT07696338","Rethinking Early Airway Clearence Therapies","REACT","Inclusion Criteria at Screening:\n\n* All genders ≥ 3 and ≤ 16 years of age\n* Documentation of a CF diagnosis\n* If capable of completing spirometry, forced expiratory volume in 1 second (FEV1) ≥ 70 % predicted at the Screening Visit\n* Clinically stable with no significant changes in health status within the 28 days prior to and including Screening Visit\n* MBW test meets acceptability criteria at the Screening Visit\n* On elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) or vanzacaftor\u002Ftezacaftor\u002Fdeutivacaftor (VTD) for at least 90 days prior to and including Screening (modified dose permissible) and willing to continue daily use of either ETI or VTD for the duration of the study\n\nInclusion Criteria at Randomization:\n\n* Clinically stable with no significant changes in health status for 28 days prior to Visit 1\n* MBW test meets acceptability at Visit 1\n* Completed at least 60% of weekly electronic treatment diaries\n* Take at least one dose of ETI or VTD per weekly electronic treatment diaries\n\nExclusion Criteria at Screening:\n\n* No use of an investigational drug within 28 days prior to and including Screening Visit\n* No initiation of new chronic therapy (e.g., azithromycin, inhaled tobramycin, inhaled aztreonam) within 28 days prior to and including Screening Visit\n* No acute use of antibiotics (oral, inhaled, or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Screening Visit\n* No antibiotic treatment for nontuberculous mycobacteria (NTM) within 28 days prior to and including the Screening Visit\n\nExclusion Criteria at Visit 1:\n\n* No acute use of antibiotics (oral, inhaled or IV), systemic corticosteroids, hypertonic saline, or dornase alfa for respiratory tract symptoms within 28 days prior to and including Visit 1\n* No absolute decrease in FEV1 % predicted of ≥10% from the Screening Visit to Visit 1 (in participants who performed acceptable and reproducible spirometry at both visits)","ALL","3 Years","16 Years",{"count":20,"type":21},405,"ESTIMATED","INTERVENTIONAL",[24],"NA","The REACT trial consists of two parallel, randomized studies; the Hypertonic Saline Study and the Dornase Alfa Study.\n\nHealth outcomes among people with cystic fibrosis (CF) have been steadily improving, most recently with the advent of highly effective modulator therapy (HEMT). While therapies like hypertonic saline (HS) and dornase alfa (DA) improved outcomes in the past, they are often burdensome. Now that almost 90% of the North American CF population is being treated with elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) or vanzacaftor\u002Ftezacaftor\u002Fdeutivacaftor (VTD), this trial will evaluate whether these newer treatments make daily HS or DA unnecessary. The trial begins with a 6-week run-in period where participants continue ETI or VTD but stop using HS and DA. Eligible participants are then assigned to either the HS Study or the DA Study for one year. Within those groups, they are randomized to either daily use of HS or DA or as needed use only during respiratory illnesses. The study aims to find out if lung health is similar between children and teens taking HEMT who use HS or DA treatments daily and those who use HS or DA treatments only when they are sick.",[27],"Cystic Fibrosis (CF)",[29,30,31,32,33,34,35,36,37,38,39,40,41,14,42],"CF","Cystic Fibrosis","Multiple Breath Washout","MBW","Lung Clearance Index","LCI","People with CF","Hypertonic Saline","Dornase Alfa","Pulmozyme","Trikafta","Alyftrek","ETI","VTD","NOT_YET_RECRUITING","2026-07-06",{"date":46,"type":47},"2026-07-10","ACTUAL",{"date":49,"type":21},"2026-09-15",{"date":51,"type":21},"2030-02-28",{"name":53,"class":54},"Nicole Hamblett","OTHER",39,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100554861","a-research-study-to-advance-the-cf-therapeutics-pipeline-for-people-without-modulators-100554861","NCT06504589","A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators","Consent\n\nA. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian\n\nB. Is willing and able to adhere to the study visit schedule and other protocol requirements\n\nDemographics\n\nA. ≥ 12 years of age at Visit 1\n\nMedical History\n\nA. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period\n\nDisease History\n\nA. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n* Sweat chloride ≥ 60 mEq\u002Fliter by quantitative pilocarpine iontophoresis test (QPIT)\n* Two well-characterized disease-causing pathogenic variants in the CFTR gene\n\nor\n\n* One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol\u002Fliter with permission of the study sponsor-investigators\n\nB. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1\n\nC. Does not have a history of lung transplantation\n\nConcomitant Medications\n\nA. Not genetically eligible for a CFTR modulator according to product label indications and\u002For No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period\n\nB. No use of an investigational drug within 90 days prior to and including Visit 1\n\nC. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and\u002For behavioral intervention trials is allowed.\n\nD. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1\n\nE. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1","12 Years",{"count":64,"type":21},400,"OBSERVATIONAL","The REACH study is for people with CF who do not take cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The goal of the REACH study is to collect research data, including health data and specimens, from people with CF who do not take CFTR modulators. This data may be used to inform CF research, help design CF clinical trials and support the development of new treatments for people with CF who do not take CFTR modulators.\n\nAnother goal of this study is to learn about research involvement for people with CF who do not take CFTR modulators, engage them in research, and give them an opportunity to learn about what is involved in participating in a CF research study.",[30],[69,35],"ineligible and\u002For not taking CFTR modulators","RECRUITING","2025-09-25",{"date":73,"type":47},"2025-10-01",{"date":75,"type":47},"2024-09-18",{"date":77,"type":21},"2029-08-14",{"name":53,"class":54},68,""]