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

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inhaled 7% HS (NaCl) home treatment

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Bronchitis, Hypertonic Saline

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Age 40-80 years, inclusive
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.
Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and FEV1/forced vital capacity (FVC) < 70%
Produces mucus at least 2 days per week, on average
History of smoking (≥ 10 pack years) -

Exclusion Criteria:

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

Uses oxygen continuously during daytime hours (nighttime use OK)
Requires > 10mg per day of prednisone (or equivalent corticosteroid dose) chronically
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
Recent change in respiratory medications, including acute antibiotic or systemic corticosteroid interventions within the last 4 weeks
History of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonist
Significant broncho reactivity by examination or pulmonary function testing (PFT), that in the opinion of the investigator would increase the risk of HS use
Radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study
Subjects with a positive pregnancy test
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.

Sites / Locations

University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

AB: 7% HS home tx, then 0.12% NaCl

BA: 0.12% NaCl home tx, then 7% HS

Arm Description

Inhaled Inhaled 7% HS (hypertonic saline) home treatment' , then 0.12% sodium chloride solution home treatment. The intervention consists of the subject receiving both concentrations of inhaled sodium chloride solution, each during a different home treatment periods. 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 Inhaled 7% HS home treatment during the second home treatment period.

Outcomes

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.

Using a gamma camera and inhalation of technicium bound to sulfur colloid, mucus clearance can be measured. Will do this with two different types of inhaled saline.

Secondary Outcome Measures

We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations.

Full Information

NCT ID

NCT01792271

First Posted

February 8, 2013

Last Updated

June 22, 2017

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01792271

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis

Keywords

COPD, Chronic Bronchitis, Hypertonic Saline

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AB: 7% HS home tx, then 0.12% NaCl

Arm Type

Placebo Comparator

Arm Description

Arm Title

BA: 0.12% NaCl home tx, then 7% HS

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Inhaled 7% HS (NaCl) home treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Description

Using a gamma camera and inhalation of technicium bound to sulfur colloid, mucus clearance can be measured. Will do this with two different types of inhaled saline.

Time Frame

Approximately 11 weeks

Secondary Outcome Measure Information:

Title

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

Other Pre-specified Outcome Measures:

Title

Changes in lung function testing (spirometry)

Time Frame

within 11 weeks of enrollment of subjects

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Volunteers who meet all of the following criteria will be eligible for study participation: Age 40-80 years, inclusive 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. Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and FEV1/forced vital capacity (FVC) < 70% Produces mucus at least 2 days per week, on average History of smoking (≥ 10 pack years) - Exclusion Criteria: Volunteers will be excluded from the study if they meet any of the following criteria: Uses oxygen continuously during daytime hours (nighttime use OK) Requires > 10mg per day of prednisone (or equivalent corticosteroid dose) chronically 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 Recent change in respiratory medications, including acute antibiotic or systemic corticosteroid interventions within the last 4 weeks History of intolerance or hypersensitivity to hypertonic saline or short acting inhaled beta agonist Significant broncho reactivity by examination or pulmonary function testing (PFT), that in the opinion of the investigator would increase the risk of HS use Radiation exposure within the 12 months prior to study participation that would cause them to exceed Federal Regulations by participating in this study Subjects with a positive pregnancy test 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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashley G Henderson, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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