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

NCT01617369 | Completed Results FDA Device

• 1 other identifier: 11-1932
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.
2. 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Change in Whole Lung Mucociliary Clearance

  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

  30 minutes and 4 hours after inhalation

Study Arms (2)

Acute Hypertonic Saline Effect

EXPERIMENTAL

2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.

Device: Hypertonic Saline

Sustained Hypertonic Saline Effect

ACTIVE COMPARATOR

2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.

Device: Hypertonic Saline

Interventions

Hypertonic Saline DEVICE

2.8% NaCl x 4ml via nebulizer

Acute Hypertonic Saline Effect; Sustained Hypertonic Saline Effect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Dr. Scott Donaldson
• Organization: University of North Carolina Chapel Hill

scott_donaldson@med.unc.edu

919-966-9198

Study Officials

• Scott Donaldson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects completed mucociliary clearance measurements (via gamma scintigraphy) at baseline, 30 minutes after inhaling 2.8% NaCl, and 4 hours after inhaling 2.8% NaCl at separate study visits to characterize acute vs. sustained effects of inhaled 2.8% NaCl on this physiologic process.

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 12, 2012
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2014-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)