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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617369
First Posted: June 12, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Scott Donaldson, MD, University of North Carolina, Chapel Hill
  Purpose

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.

Condition Intervention
Healthy Subjects Device: Hypertonic Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects

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

Primary Outcome Measures:
  • 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



Enrollment: 12
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute Hypertonic Saline Effect
2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.
Device: Hypertonic Saline
2.8% NaCl x 4ml via nebulizer
Active Comparator: Sustained Hypertonic Saline Effect
2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.
Device: Hypertonic Saline
2.8% NaCl x 4ml via nebulizer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617369


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Gilead Sciences
Investigators
Principal Investigator: Scott Donaldson, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Scott Donaldson, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01617369     History of Changes
Other Study ID Numbers: 11-1932
First Submitted: June 6, 2012
First Posted: June 12, 2012
Results First Submitted: February 15, 2017
Results First Posted: April 4, 2017
Last Update Posted: May 4, 2017
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes