Clearance in Primary Ciliary Dyskinesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
BehavioralAt 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.
HS pretreatment with Exercise
Other interventionAt 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.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Exercise with and without HS pretreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Whole Lung Total GLT
Through MCC scan with built in exercise protocol, the investigators will measure the effects of exercise on rates of clearance of radiolabeled isotopes from the lungs, thought to represent GLT. The investigators will measure the difference between retained particles from immediately before (after collection of 16 minutes of baseline MCC data through eight 2-minute images) and immediately after 20 minutes of moderate intensity exercise on a cycle ergometer (40 minutes after start of MCC data collection). This will represent Active GLT. The investigators will then resume measurement of MCC clearance rate by serial 2-minute image collection of the whole lung from 40 minutes to 70 minutes. This will represent Sustained GLT. The sum of Active and Sustained GLT will represent Whole Lung GLT. This measurement will occur at either Visit 2 or Visit 3, depending on visit sequence randomization.
Time frame
Either Day 1 (Visit 2) or up to Day 28 (Visit 3) depending on randomization to sequence intervention2
Change in Whole Lung Total GLT after HS pretreatment
After pretreatment with levalbuterol and 7% HS, participants will undergo an MCC scan with built in exercise protocol. The investigators will measure the effects of exercise on rates of clearance of radiolabeled isotopes from the lungs, thought to represent GLT. The investigators will measure Active GLT and Sustained GLT after HS pretreatment, which taken together will represent Whole Lung GLT after HS pretreatment. This measurement will occur at either Visit 2 or Visit 3 depending on visit sequence randomization. The difference between Whole Lung GLT from exercise alone will be compared with the HS pretreatment Whole Lung GLT.
Time frame
Day 3 to 28, depending on timing of Visit 33
Change in Cough Clearance (CC) after HS Pretreatment
The investigators will measure the effects of exercise and HS pretreatment on rates of clearance of radiolabeled isotopes from the lungs during a period of controlled coughs at regular intervals. During Visit 2 and Visit 3 MCC scans, from minutes 70 through 100 of MCC data collection, participants will be instructed to perform 30 voluntary huff-cough maneuvers while serial 2-minute images are obtained. The change in clearance during this time will represent CC. At one of these visits (either Visit 2 or Visit 3 depending on randomization to intervention sequence), participants will undergo pretreatment with levalbuterol and 7% HS prior to the MCC scan with exercise protocol. The difference between CC after exercise alone and CC after exercise with HS pretreatment will be measured.
Time frame
Day 3 to 28, depending on timing of Visit 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov
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