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

NCT02341183 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-06-23

No results posted yet for this study

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.

Conditions

  • COPD
  • Chronic Bronchitis

Interventions

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Scott H. Donaldson, MD · Associate Professor, Department of Medicine, Division of Pulmonary/Critical Care Medicine, UNC Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-05-31
Completion
2016-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02341183 on ClinicalTrials.gov