Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CF Therapeutics Development Network Coordinating Center
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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