Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects

The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.

Objectives:

1. The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects. 2. The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects, without respiratory or cardiac comorbidities
Age 18-55 years, inclusive
FEV1 > 80% predicted and FEV1/FVC ratio >70%
Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation
Subjects who are capable of providing their written informed consent to participate in the study

Exclusion criteria

History of smoking > 10 pack-years
Any history of smoking within 60 days of screening
Acute upper or lower respiratory illness within 30 days of screening
Respiratory medication for any indication within 30 days of screening
History of asthma, chronic bronchitis, or other chronic lung disease
History of intolerance to hypertonic saline
Women who are pregnant, lactating, or of childbearing potential who are unwilling to use an acceptable method of contraception throughout the duration of the study.
Any condition that, in the opinion of the investigator, would potentially jeopardize the safety of the participant or the integrity of the study
History of radiation exposure within the past year that would cause the subject to exceed limits for adults established by Federal Regulations
Subjects who, in the opinion of the Principal Investigator, should not participate in the study

Treatment and study plan

Hypertonic Saline

Device

2.8% NaCl x 4ml via nebulizer

Primary outcomes

Change in Whole Lung Mucociliary Clearance

Time frame: 30 minutes and 4 hours after inhalation

The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.

Absolute change in MCC-Ave90 from baseline reported for each arm

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

Gilead Sciences

Registry information

Official study title

A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 12, 2012
Registry last updated: May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed