Exercise + Hypertonic Saline for Primary Ciliary Dyskinesia

(CLIP Trial)

KA
CT
Overseen ByCorinne Taylor
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

KA

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

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)
I am 18 years old or older.
See 1 more

Exclusion Criteria

Intolerance to levalbuterol
I have had a lung flare-up in the past 4 weeks.
Intolerance to 7% HS
See 12 more

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

Group I: Exercise with and without HS pretreatmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

Cystic Fibrosis Foundation

Collaborator

Trials
199
Recruited
37,800+