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Multicenter Study
. 2011 Jul;46(7):666-71.
doi: 10.1002/ppul.21425. Epub 2011 Mar 1.

Inhaled hypertonic saline in infants and toddlers with cystic fibrosis: short-term tolerability, adherence, and safety

Margaret Rosenfeld  1 , Stephanie Davis, Lyndia Brumback, Stephen Daniel, Ron Rowbotham, Robin Johnson, Sharon McNamara, Renee Jensen, Carol Barlow, Felix Ratjen
Affiliations
Multicenter Study

Inhaled hypertonic saline in infants and toddlers with cystic fibrosis: short-term tolerability, adherence, and safety

Margaret Rosenfeld et al. Pediatr Pulmonol. 2011 Jul.

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 One was withdrawn due to maternal concern over fussiness with application of the facemask for the test dose. Of the 19 participants administered the test dose, 1 was withdrawn due to test dose intolerance (5%, 95% confidence interval 0, 26%). Eighteen participants completed the study; 1 was intolerant (95% CI 0, 27%) at the final visit due to new wheezes on exam in association with an upper respiratory infection and otitis media. Home symptom diaries demonstrated cough as the main symptom in the hour following inhalation, which decreased in frequency over the study period. Adherence as assessed by daily home diary and returned study drug ampoules was high. Participants reported receiving both treatments on a median of 100% of days; a median of 25 ampoules were used during a median of 13 days.

Conclusions: 7% HS appears well tolerated for up to 14 days in infants and toddlers with CF, with high adherence. These results provide encouraging short-term tolerability and adherence data for future trials assessing the safety and efficacy of 7% HS in young children with CF.

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Figures

Figure 1
Figure 1
Respiratory rate and oxygen saturation versus time in study participants. For time, B refers to baseline. Subsequent tick marks are at 10 minutes after baseline (oxygen saturations only), completion of the HS test dose, 20 and 30 minutes later, and the final study visit (day 14). Gray indicates subjects who were tolerant to the test dose. Black indicates subjects who were intolerant to test dose. X indicates subject who withdrew after <1 minute of test dose exposure.
See this image and copyright information in PMC

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