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Study Name: Pilot Safety Study of Inhaled 7% Hypertonic Saline in Infants with CF
Study Type: Interventional
Intervention Category: Restore Airway Surface Liquid
Study Sponsor: Rosenfeld, Margaret

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: 25
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This pilot study evaluated the tolerability of hypertonic saline (HS) given for up to 14 days in infants with CF ages 4 to 15 months of age. After the results of this study are available, a longer duration study to evaluate the efficacy of hypertonic saline known as the "Infant Study of Inhaled Saline" or the ISIS trial will begin.
ELIGIBILITY
Age: 12 Months - 30 Months
FEV1: Not Applicable
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: Rowbotham, Ron
(206) 884-7550
ronald.rowbotham@seattlechildrens.org
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00546663?term=cystic+fibrosis&rank=60
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Not Applicable

Secondary Efficacy:

Not Applicable

Safety:

In this open-label study, infants were given a single test dose of hypertonic (7%) saline and evaluated for tolerability before they were sent home to take the medication for 14 days twice daily. Twenty infants were given a single test dose by facemask; 18 of these infants tolerated the test dose and were provided with 14 days of medication. All 18 infants finished the study. At the end of 14 days of dosing, tolerability in one infant could not be determined due to acute respiratory infection. The remaining 17 infants were found to tolerate the medication as determined by no change in respiratory rate, oxygen saturation, and no new wheeze or rales on chest examination.
The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2008). These data may be preliminary and have not been peer-reviewed.

Citation:

Pediatr Pulmonol 2011;46(7):666-671

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