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Study Name: Surfactant and Hypertonic Saline
Study Type: Interventional
Intervention Category: Restore Airway Surface Liquid
Study Sponsor: Donaldson, Scott

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Trial Completed
Study Drug(s): Hypertonic Saline
Number of Participants Being Recruited: 16
Single / Multi-Center: Single Center
STUDY BACKGROUND INFORMATION:
People with CF have difficulty clearing mucus from their airway. This causes the airway to become obstructed with mucus and infected with bacteria. Medications are available that help clear mucus but do not completely correct the mucus obstruction because of the strong interaction between dehydrated CF mucus and airway surfaces. This study will seek to improve mucus clearance in people with CF through the use of aerosolized surfactant.

Surfactant is naturally produced in the lung and plays a number of critical functions there. Surfactant helps prevent alveoli from collapsing during exhalation; helps inflammatory cells surround and kill inhaled microorganisms; and aids in the clearance of airway mucus. Surfactant acts much like detergent to reduce the ability of mucus to stick to airway surfaces.

This study proposes to test the ability of inhaled surfactant to lessen the obstruction of CF airways and to improve mucus clearance. Because surfactant may be particularly effective after hydrating CF secretions with hypertonic saline, the study will compare the effect of surfactant treatment to surfactant plus hypertonic saline treatment.
ELIGIBILITY
Age: >= 14 Years
FEV1: >= 40 Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Donaldson, Scott
(919) 966-9198
scott_donaldson@med.unc.edu
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/ct2/show/NCT00934362?term=donaldson+and+cystic+fibrosis&rank=2
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
NC
  • University of North Carolina at Chapel Hill (Adult), Chapel Hill, NC, 27599
    Contact Information:
        Shive, Nadia
        Phone: (919) 966-9198
        Email: nadiab@med.unc.edu
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