Clearance in Primary Ciliary Dyskinesia (NCT07699302) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clearance in Primary Ciliary Dyskinesia
United States8 participantsStarted 2026-07-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Whole Lung Total GLT
Timeframe: Either Day 1 (Visit 2) or up to Day 28 (Visit 3) depending on randomization to sequence intervention
2
Change in Whole Lung Total GLT after HS pretreatment
Timeframe: Day 3 to 28, depending on timing of Visit 3
3
Change in Cough Clearance (CC) after HS Pretreatment
Timeframe: Day 3 to 28, depending on timing of Visit 3