title: Safety and tolerability of inhaled hypertonic saline in young children with cystic fibrosis.
abstract: BACKGROUND
  Inhaled hypertonic saline (HS) improves lung function and decreases pulmonary exacerbations in older patients with cystic fibrosis (CF). Initiating therapies in young patients has potential to preserve lung function. Before conducting a therapeutic trial of HS in this population, its safety must be evaluated and protocols for monitoring response must be tested.
  
  
  METHODS
  We administered single dose 3% and 7% HS post-albuterol to 4-7 year-olds with CF able to perform spirometry ("preschool" group) and 4 month to 3 year-olds ("infant" group) using the raised volume rapid thoracoabdominal compression technique (RVRTC). Vital signs and cough episodes were measured after each inhaled treatment.
  
  
  RESULTS
  Eight preschool subjects (mean age 5.7 +/- 0.8 years) and 6 infants (1.6 +/- 1.0 years) completed the 3% HS protocol, and no clinically important change in vital signs or decrease in FVC, FEV(1), FEV(0.5), or FEF(25-75) occurred post-HS. Preschoolers had more cough episodes post-HS (P = 0.01). Seven preschoolers (6.1 +/- 0.7 years) and 8 infants (1.6 +/- 0.7 years) completed the 7% HS protocol. In the preschool group, FVC, FEV(0.5), and FEF(25-75) did not change significantly. A statistically significant drop in median FEV(1) occurred post-7% HS attributable to a transient >20% drop in one subject. Infant PFT parameters were unchanged post-7% HS. Preschoolers had more cough episodes post-HS (P = 0.03).
  
  
  CONCLUSIONS
  Acute administration of 3% and 7% HS appears to be safe and well-tolerated in most young children with CF. Given the demonstrated benefits in older patients, a therapeutic trial in this age group is warranted.
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: Elisabeth P
authors.initials: EP
authors.lastname: Dellon
authors.affiliation: Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: Scott H
authors.initials: SH
authors.lastname: Donaldson
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: Robin
authors.initials: R
authors.lastname: Johnson
authors.affiliation: Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors.forename: Stephanie D
authors.initials: SD
authors.lastname: Davis
mesh_terms: D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage; D001993:Bronchodilator Agents / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D012129:Respiratory Function Tests; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage / Q000009:adverse effects*; D013501:Surface-Active Agents / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D001993:Bronchodilator Agents; D012462:Saline Solution, Hypertonic; D013501:Surface-Active Agents; D000420:Albuterol