NCT02341183

Novel Therapies for Muco-Obstructive Lung Diseases: Testing the Transnasal Pulmonary Delivery Device in COPD/CB Subjects

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• COPD
• Chronic Bronchitis

Interventions

Type	Name	Description
DEVICE	tPAD	7% NaCl administered continuously for 8 hours, overnight, via the tPAD device
DEVICE	7% hypertonic saline (510K approved as a device)	Subjects will receive overnight treatments of 7% HS via the tPAD device in both comparators, but in a randomly assigned order as described.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-01-19
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study