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Inhaled Hypertonic Saline in Infants and Toddlers with Cystic Fibrosis: Short-term Tolerability, Adherence, and Safety by Margaret Rosenfeld; Stephanie Davis; Lyndia Brumback; Stephen Daniel; Ron Rowbotham; Robin Johnson; Sharon McNamara; Renee Jensen; Carol Barlow; Felix Ratjen is a Medicine article available to read on EtoBox.

What is Inhaled Hypertonic Saline in Infants and Toddlers with Cystic Fibrosis: Short-term Tolerability, Adherence, and Safety about?

## Abstract ## Background Inhaled hypertonic saline (HS) is an attractive agent for chronic maintenance therapy in infants and toddlers with cystic fibrosis (CF) because it improves defective mucociliary clearance. Prior to undertaking a clinical trial of HS efficacy in young children with CF, tolerability, adherence, and safety must be established. ## Methods Three‐center, open label evaluation of the short‐term tolerability, adherence, and safety of 7% HS administered twice daily for 14 days in children with CF 12–30 months of age. The primary objective was to evaluate the proportion of participants unable to tolerate single and repeated doses of 7% HS according to protocol‐defined criteria. Participants inhaled a test dose of HS at the enrollment visit; test dose intolerance was defined as fulfillment of at least one of 4 criteria. Participants who tolerated the test dose inhaled 7% HS twice daily for 14 ± 2 days. ## Results Twenty children were enrolled. One was withdrawn due to maternal concern over fussiness with application of the facemask for the test dose. Of the 19 participants administered the test dose, 1 was withdrawn due to test dose intolerance (5%, 95% confidence in

Who reads Inhaled Hypertonic Saline in Infants and Toddlers with Cystic Fibrosis: Short-term Tolerability, Adherence, and Safety?

Author

Margaret Rosenfeld; Stephanie Davis; Lyndia Brumback; Stephen Daniel; Ron Rowbotham; Robin Johnson; Sharon McNamara; Renee Jensen; Carol Barlow; Felix Ratjen

Publisher

John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 8755-6863)

Published

2011

Language

EN

Field

Medicine (Health Sciences)