Aptalis announced the results of a global Phase 3 study of Aeroquin (levofloxacin inhalation solution) conducted in cystic fibrosis patients with stable chronic lung infection with Pseudomonas aeruginosa. Aeroquin is a proprietary formulation of levofloxacin for aerosol delivery using an investigational eFlow Nebulizer System. Levofloxacin is a fluoroquinolone antibiotic.
In the randomized open-label Phase 3 study (Study 209), conducted in 282 patients, Aeroquin was compared to tobramycin for inhalation solution (Tobi; Novatis). The trial consisted of three 28-day on/off treatment cycles. Patients had been heavily pretreated with inhaled antibiotics prior to enrollment. The primary endpoint – non-inferiority of relative change from baseline in percent predicted Forced Expiratory Volume in 1 Second (FEV1) after the first treatment cycle of 28 days – was met. This effect with Aeroquin on lung function was maintained over all three treatment cycles (ie, through Day 168).
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