[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054091":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":38,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":21,"enrollmentInfo":71,"targetDuration":21,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":89,"whyStopped":21,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise with and without HS pretreatment","EXPERIMENTAL","All participants will undergo interventions of exercise alone, and exercise with HS pretreatment, in two separate study visits according to randomization to intervention sequence.",[13,14],"Behavioral: Exercise","Other: HS pretreatment with Exercise",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BEHAVIORAL","Exercise","At either V2 or V3, after 16 minutes of baseline MCC data collection, participants will perform 20 minutes of moderate-intensity exercise based on the Borg Rating of Perceived Exertion (RPE) scale, on a cycle ergometer. The goal through this moderate intensity exercise is to increase respiratory rate and airflow velocity, thereby potentially inducing GLT. Participants will then resume MCC scan data collection post-exercise to continue to measure the effects induced by exercise on clearance from the lungs.",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"HS pretreatment with Exercise","At either V2 or V3, prior to the start of baseline MCC scanning, participants will undergo pretreatment with 4 puffs of inhaled levalbuterol (90 mcg per actuation, via spacer) followed by 4 ml of 7% HS via nebulizer. Participants will then start MCC scan data collection, and after 16 minutes of baseline MCC collection they will then complete 20 minutes of moderate intensity exercise according to the Borg RPE on a cycle ergometer. After 20 minutes, MCC scan will resume to continue to measure rates of clearance following HS pretreatment and exercise.",[9],[27],{"name":28,"affiliation":5,"role":29},"Katherine A Despotes, MD","PRINCIPAL_INVESTIGATOR",[31,35],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},"CONTACT","919-966-1055","katherine.despotes@unchealth.unc.edu",{"name":36,"role":32,"phone":21,"phoneExt":21,"email":37},"Corinne Taylor","corinne.lawler@unc.edu",[39],{"facility":40,"status":21,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27278","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-79.05584,35.9132,{"lat":50,"lon":49},[53,54,55],{"name":28,"role":32,"phone":33,"phoneExt":21,"email":34},{"name":36,"role":32,"phone":21,"phoneExt":21,"email":37},{"name":28,"role":29,"phone":21,"phoneExt":21,"email":21},{"type":57,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[59],{"name":60,"class":6},"Cystic Fibrosis Foundation","100054091","clearance-in-primary-ciliary-dyskinesia-100054091",false,"NCT07699302","Clearance in Primary Ciliary Dyskinesia","Evaluating Non-ciliary Mechanisms of Airway Clearance in Muco-obstructive Lung Disease","CLIP","Inclusion Criteria:\n\n* 18 years old or older\n* Diagnosis of PCD with supporting genetics\n* Lung function with forced expiratory volume in 1 second (FEV1) percent predicted \\>30%\n* Ability to exercise for 20 minutes (Exercise Assessment performed at screening visit)\n\nExclusion Criteria:\n\n* Intolerance to 7% HS\n* Failure of HS tolerance test (HSTT) at visit 1 (V1), defined as a decline of 10% in FEV1 from baseline pre-bronchodilator (BD) FEV1 after 7% HS\n* Intolerance to levalbuterol\n* Exercise-induced asthma\n* Complex congenital heart disease or other exercise limitation\n* Lung transplantation or listed for lung transplantation\n* History of lung resection of the lung analyzed by MCC (depending on situs status)\n* Pregnancy or unwillingness to use approved birth control during study period\n* Recent hemoptysis (\\>60 ml in the last 3 months)\n* Pulmonary exacerbation in preceding 4 weeks\n* Change in pulmonary therapies within preceding 4 weeks\n* Resting or exertional O2 requirement (nocturnal acceptable)\n* Tobacco \u002F smoking history (any within last year, and \\>10 pack year history in past)\n* More than 2 chest computed tomography (CT) scans in the past year or a combination of procedures believed to have exposed the lungs to \\>150 millisieverts (mSv), including from other research studies\n* Participation in another interventional trial within 30 days","ALL","18 Years",{"count":72,"type":73},8,"ESTIMATED","INTERVENTIONAL",[76],"NA","Understanding mechanisms of mucus clearance from the airways may lead to treatments in muco-obstructive lung conditions. Mucociliary clearance (MCC) scans are a way to measure the rate at which a person's lungs can clear inhaled particles. Through a single-arm pilot study in participants with primary ciliary dyskinesia (PCD), the investigators will evaluate the effect of exercise as a way to increase clearance through a mechanism called gas liquid transport (GLT) where the faster flow of air through the lungs during exercise is able to clear more particles. The investigators will repeat MCC measures with exercise after administering hypertonic saline (HS) to evaluate the effects of mucus hydration on both GLT and cough clearance (CC).\n\nAim 1. To quantify non-ciliary, non-cough mechanisms of mucus clearance (i.e., GLT) in PCD through an MCC protocol that introduces a standardized exercise intervention after isotope delivery.\n\nAim 2. To evaluate whether exercise-induced GLT and\u002For CC are responsive to hydrator intervention, using a short acting bronchodilator with 7% HS prior to isotope delivery followed by MCC with exercise intervention.",[79,80],"Primary Ciliary Dyskinesia","PCD",[82,83,84,85,86,87,88],"exercise","primary ciliary dyskinesia","airway clearance","mucociliary clearance","hypertonic saline","cough clearance","gas liquid transport","NOT_YET_RECRUITING","2026-07-09",{"date":92,"type":93},"2026-07-13","ACTUAL",{"date":95,"type":73},"2026-07-30",{"date":97,"type":73},"2027-01",{"name":5,"class":6},1]