COPD Clinical Trial
Official title:
Novel Therapies for Muco-Obstructive Lung Diseases: A Study of Tolerability and MCC Effect of Hypertonic Saline Delivered Via the tPAD in Patients With Chronic Bronchitis
The primary objective of this study is to assess tolerability and effect of HS (hypertonic saline) delivered with the tPAD (transnasal Pulmonary Aerosol Delivery) device on mucociliary clearance (MCC) in chronic obstructive pulmonary disease/chronic bronchitis (COPD/CB) subjects. The investigators hypothesize that HS delivery via tPAD will be safe and and while, and will improve MCC.
The beneficial effects of inhaled HS in CF patients (cystic fibrosis) have been well
established. Concerns over safety and intolerability in patients with COPD/CB, based in part
upon experiences with ultrasonic delivery devices, have limited interest in further
exploring this therapeutic option. Although our clinical data suggests that HS delivered via
jet nebulizer is generally well tolerated in patients with COPD/CB, our pre-clinical data
suggests that cell shrinkage, the release of proinflammatory cytokines (i.e. IL-8), and
transient cilia stasis is dependent upon the rate of aerosol delivery.
Slow/continuous delivery may avoid most/all of these detrimental effects while promoting an
even greater cumulative ASL (airway surface liquid) volume increase. To translate these data
into a feasible treatment strategy, a comfortable, quiet delivery device that can be used
for long time periods (i.e. overnight) was developed to slowly deliver HS via a nasal
cannula device while avoiding aerosol rain-out in the device's tubing. Use of a
computational model (MPPD: Multiple-Path Particle Dosimetry V2.0) predicts that this device,
which generates a 2 um MMAD aerosol particle, will achieve -5-8% lung deposition. When tuned
to an output of ~0.033 ml/min, 8 hours of use is predicted to deposit a minimum of 140 mg of
NaCI onto airway surfaces. This compares favorably to the estimated mass delivered via jet
nebulizer in the clinically successful study of HS in CF (110 mg/day, assuming 19.75%
deposition fraction with the Pari LC PLUS).
The proposed study is a single site, randomized, open label, cross-over trial designed to
measure the tolerability and effect on mucociliary clearance following 7% HS delivered via
tPAD for eight hours overnight to COPD/CB subjects. Comparison will be to measurements made
following no treatment during an overnight stay. COPD/CB subjects meeting inclusion and
exclusion criteria will be enrolled in the study. All study procedures will be conducted in
the Clinical Translational Research Center (CTRC) at UNC Hospitals and the EPA building on
Mason Farm Rd on the UNC Hospitals campus.
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