High-dose ibuprofen in cystic fibrosis: Canadian safety and effectiveness trial

J Pediatr. 2007 Sep;151(3):249-54. doi: 10.1016/j.jpeds.2007.04.009. Epub 2007 Jun 26.


Objective: To assess the effectiveness and safety of high-dose ibuprofen when used as part of routine therapy in patients with cystic fibrosis (CF).

Study design: In this multicenter, double-blinded, placebo-controlled trial, a total of 142 patients age 6 to 18 years with mild lung disease (forced expiratory volume in 1 minute [FEV1] > 60 predicted) were randomized to receive either high-dose ibuprofen (70 subjects, 20 to 30 mg/kg/twice daily, adjusted to a peak serum concentration of 50 to 100 mug/mL) or placebo (72 subjects) for a 2-year period. The primary outcome was the annualized rate of change in FEV1% predicted.

Results: The patients in the high-dose ibuprofen group exhibited a significant reduction in the rate of decline of forced vital capacity percent predicted (0.07 +/- 0.51 vs -1.62 +/- 0.52; P = .03), but not FEV1%. The ibuprofen group also spent fewer days in hospital after adjusting for age (1.8 vs 4.1 days per year; P = .07). A total of 11 patients (4 in the ibuprofen group and 7 in the placebo group) withdrew due to adverse events.

Conclusions: High-dose ibuprofen has a significant effect on slowing the progression of lung disease in CF and generally is well tolerated.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / pharmacokinetics
  • Canada
  • Child
  • Chromatography, High Pressure Liquid
  • Cystic Fibrosis / drug therapy*
  • Double-Blind Method
  • Female
  • Forced Expiratory Volume
  • Humans
  • Ibuprofen / administration & dosage*
  • Ibuprofen / pharmacokinetics
  • Male
  • Patient Selection
  • Regression Analysis
  • Vital Capacity


  • Anti-Inflammatory Agents, Non-Steroidal
  • Ibuprofen