Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.

Key facts

Study ID: NCT00546663
Run by: CF Therapeutics Development Network Coordinating Center
People needed: 19
Starts: 2007-09-01
Expected to finish: 2008-07-01
Last updated by the study team: 2011-08-24

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of CF as defined by one or more clinical features of CF and a documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
Informed consent by parent or legal guardian
12-30 months of age at enrollment

You may not qualify if…

Wheezing at the baseline evaluation at the enrollment visit
Oxygen saturation < 95 % at the baseline evaluation at the enrollment visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate, or new rhinorrhea, nasal congestion or rhinorrhea, with onset in the week preceding the enrollment visit
Investigational drug use within 30 days prior to the enrollment visit
Known intolerance of albuterol
Current enrollment in a therapeutic clinical trial
Condition or situation which, in the opinion of the investigator, would affect the ability of the patient or family to complete study procedures

Where it is running

University of North Carolina — Chapel Hill, North Carolina, United States
Children's Hospital and Regional Medical Center — Seattle, Washington, United States
Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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