TOBI®: PROVEN TO HELP IMPROVE LUNG FUNCTION IN CF PATIENTS WITH Pa1

TOBI demonstrated a significant improvement in FEV1
in CF patients with Pa in the lungs2


In pivotal studies with TOBI, lung function benefits were seen in patients with CF with a positive Pa sputum/throat culture within the last 6 months and a minimum of 1 screening visit.3

At 20 weeks TOBI produced a 12% improvement in FEV1 compared to placebo

Results from 2 identical, randomized, multicenter, double-blind, placebo-controlled trials. Patients were treated with 300 mg of aerosolized tobramycin (n=258) or placebo (n=262) twice daily in 3 cycles, with each cycle consisting of 28 days during which the drug was administered and 28 days during which the drug was not administered. The shaded areas denote the periods when patients received TOBI or placebo. The primary efficacy end point was change in FEV1 at week 20.1,4

TOBI significantly decreased sputum bacterial density of Pa1

  • Sputum bacterial density decreased during on-drug periods and returned to baseline during off-drug periods1
  • Reductions in sputum bacterial density were smaller with each successive cycle1
 



Important Safety Information full Prescribing Information www.fda.gov/medwatch

References:

  • TOBI [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.
  • Moss RB. Administration of aerosolized antibiotics in cystic fibrosis patients. Chest. 2001;120:107S-113S.
  • Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.
  • Ramsey BW, Pepe MS, Quan JM, et al. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. N Engl J Med. 1999;340:23-30.