Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ashley Henderson, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01792271
First received: February 8, 2013
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of this research study is to examine the effects of two weeks of daily dosing of inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary Disease (COPD.

Defective mucociliary clearance (MCC) is central to the development and/or worsening of several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF), and bronchiectasis. In each case, defective MCC leads to the development of lung infections and damage to the airways from ongoing inflammation caused by a person's inability to clear mucus from the lungs.

The investigators' previous studies have shown that the administration of inhaled HS (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use "resets" the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and its success raises optimism that similar benefits might occur in patients with CB.

In this study the investigators will use mildly radioactive particles, technetium bound to sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with CB. We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations.

Our long term goals are to improve our understanding of MCC in health and disease and to develop better therapies that support and/or restore MCC in patients with these diseases to reduce lung infections.


Condition Intervention
Chronic Obstructive Pulmonary Disease
COPD
Chronic Bronchitis
Other: Inhaled HS home treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Novel Therapies for Muco-Obstructive Lung Diseases: Sustained Effects of Hypertonic Saline on Mucociliary Clearance and Clinical Tolerability in Subjects With Chronic Bronchitis

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of hypertonic saline versus a low salt control treatment for subjects with CB. [ Time Frame: Approximately 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations. [ Time Frame: Within 2 years after all data collection has ended ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Changes in lung function testing (spirometry) [ Time Frame: within 11 weeks of enrollment of subjects ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Inhaled HS home treatment

Inhaled 7% sodium chloride solution (NaCl)

Inhaled 0.12% sodium chloride solution (NaCl)

The intervention consists of the subject receiving both concentrations of inhaled sodium chloride solution, each during a different home treatment period. Subjects randomized to order AB will receive inhaled 7% NaCl (sodium chloride solution) mist during the first home treatment period, then 0.12% NaCL during the second home treatment period.

Subjects randomized to order BA will receive inhaled 0.12% NaCl mist during the first home treatment period, then 7% NaCl during the second home treatment period.

Other: Inhaled HS home treatment
Administering inhaled 7% NaCl for two weeks of home treatment vs. a placebo of 0.12% NaCL during a separate home treatment period, and assessing the effects of each primarily by MCC study.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Volunteers who meet all of the following criteria will be eligible for study participation:

  1. Age 40-80 years, inclusive
  2. Non-pregnant subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double barrier" method (such as diaphragm and condom), or must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
  3. Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and FEV1/forced vital capacity (FVC) < 70%
  4. Produces mucus at least 2 days per week, on average
  5. History of smoking (≥ 10 pack years) -

Exclusion Criteria:

Volunteers will be excluded from the study if they meet any of the following criteria:

  1. Uses oxygen continuously during daytime hours (nighttime use OK)
  2. Requires > 10mg per day of prednisone (or equivalent corticosteroid dose) chronically
  3. Concomitant presence of congestive heart failure, active coronary syndromes, or other disease that in the opinion of the investigator would increase the risk resulting from participation
  4. Recent change in respiratory medications, including acute antibiotic or systemic corticosteroid interventions within the last 4 weeks
  5. History of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonist
  6. Significant broncho reactivity by examination or pulmonary function testing (PFT), that in the opinion of the investigator would increase the risk of HS use
  7. Radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study
  8. Subjects with a positive pregnancy test
  9. Subjects who, in the opinion of the Principal Investigator, should not participate in the study

Subjects may be temporarily excluded from screening should they experience a respiratory tract infection that requires treatment with antibiotics and/or steroids. They may become eligible for screening four weeks after completing their treatment providing their symptoms have resolved.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792271

Contacts
Contact: Fred Fuller, BA ADN 919-966-2531 fred_fuller@med.unc.edu
Contact: Ashley Henderson, MD 919-966-2531 ashley_henderson@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Fred Fuller, BA ADN    919-966-2531    fred_fuller@med.unc.edu   
Principal Investigator: Ashley G Henderson, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Ashley G Henderson, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Ashley Henderson, MD, Prinicpal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01792271     History of Changes
Other Study ID Numbers: 12-2602, 1P01HL108808-01A1
Study First Received: February 8, 2013
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
COPD
Chronic Bronchitis
Hypertonic Saline

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Acute Disease
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014