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Study Name: Hypertonic Saline in Infants and Young Children with Cystic Fibrosis (Pilot)
Study Type: Interventional
Intervention Category: Restore Airway Surface Liquid
Study Sponsor: Davis, Stephanie

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: 1
Recruitment Status: Trial Completed
Study Drug(s): Hypertonic Saline
Number of Participants Being Recruited: 16
Single / Multi-Center: Single Center
STUDY BACKGROUND INFORMATION:
This study assessed the safety of Hypertonic Saline (HS) infants and young children with CF. This study compared lung function before and after different strengths of HS in children between the ages of 4 and 7 years. Also, oxygen levels, breathing rate, physical exam changes and a cough record before and after administration of HS were recorded. In infants lung function before and after HS was compared.
ELIGIBILITY
Age: 1 Months - 8 Years
FEV1: >= 60 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: Davis, Stephanie
(317) 948-7768
sddavis3@iu.edu
Trial Specific Link on ClinicalTrials.gov: Not Available
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Not applicable

Secondary Efficacy:

Not applicable

Safety:

The abstract presents the preliminary results on the initial 6 patients enrolled in the study and concluded that a single administration of 3% saline was well-tolerated in children age 4 months to 4 years.

The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2007). These data may be preliminary and have not been peer-reviewed.

Citation:

Not Available
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