Clearance in Primary Ciliary Dyskinesia

Starting soon · Not applicable

Conditions studied: Primary Ciliary Dyskinesia, PCD

In brief

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). Aim 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. Aim 2. To evaluate whether exercise-induced GLT and/or CC are responsive to hydrator intervention, using a short acting bronchodilator with 7% HS prior to isotope delivery followed by MCC with exercise intervention.

Key facts

Study ID

NCT07699302

Run by

University of North Carolina, Chapel Hill

People needed

8

Starts

2026-07-30

Expected to finish

2027-01-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years old or older
• Diagnosis of PCD with supporting genetics
• Lung function with forced expiratory volume in 1 second (FEV1) percent predicted >30%
• Ability to exercise for 20 minutes (Exercise Assessment performed at screening visit)

You may not qualify if…

• Intolerance to 7% HS
• 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
• Intolerance to levalbuterol
• Exercise-induced asthma
• Complex congenital heart disease or other exercise limitation
• Lung transplantation or listed for lung transplantation
• History of lung resection of the lung analyzed by MCC (depending on situs status)
• Pregnancy or unwillingness to use approved birth control during study period
• Recent hemoptysis (>60 ml in the last 3 months)
• Pulmonary exacerbation in preceding 4 weeks
• Change in pulmonary therapies within preceding 4 weeks
• Resting or exertional O2 requirement (nocturnal acceptable)
• Tobacco / smoking history (any within last year, and >10 pack year history in past)
• 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
• Participation in another interventional trial within 30 days

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.