Exercise + Hypertonic Saline for Primary Ciliary Dyskinesia
(CLIP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Katherine A Despotes, MD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for people diagnosed with primary ciliary dyskinesia (PCD), a rare lung condition that affects mucus clearance. Participants should be able to perform exercise and undergo lung scans. Specific inclusion or exclusion criteria are not detailed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Exercise
- Hypertonic Saline (HS) pretreatment
Trial Overview
The study tests if exercise alone, and exercise after inhaling hypertonic saline (a salty mist), can help clear mucus from the lungs in people with PCD. All participants receive both interventions in this small pilot study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants will undergo interventions of exercise alone, and exercise with HS pretreatment, in two separate study visits according to randomization to intervention sequence.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Cystic Fibrosis Foundation
Collaborator
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