Status:
COMPLETED
Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Obstructive Pulmonary Disease
COPD
Eligibility:
All Genders
40-80 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
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Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01792271
Start Date
February 1 2013
End Date
May 1 2016
Last Update
June 23 2017
Active Locations (1)
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1
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599