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Mixed Results With Aeroquin (Inhaled Levofloxacin) in Cystic Fibrosis Trials

Antibiotic delivered with investigational nebulizer (Jan. 7)

Mixed results have been announced from two double-blind phase III studies of Aeroquin (levofloxacin inhalation solution, Aptalis Pharma) in cystic fibrosis (CF) patients with stable chronic lung infection with Pseudomonas aeruginosa. The new trials followed a 2011 study that demonstrated a dose-dependent reduction in the sputum density of P. aeruginosa and improvement of lung function in the same patient population.

In the first phase III trial, 330 patients with CF were randomly assigned to treatment with either Aeroquin — delivered with an investigational nebulizer system (eFlow, PARI Pharma GmbH) at a dosage of 240 mg twice daily — or placebo in a single treatment cycle of 28 days. The difference between the Aeroquin and placebo groups in the predefined primary endpoint of time to first pulmonary exacerbation was not statistically significant; however, Aeroquin was effective in certain secondary endpoints (i.e., improved lung function and a reduction in P. aeruginosa from sputum).

In the second phase III study, conducted in 282 CF patients, the same dosage of Aeroquin was compared with tobramycin for inhalation solution (TIS) in three 28-day on/off treatment cycles. In this study, the primary endpoint — non-inferiority of the 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 (i.e., through day 168). For other clinically relevant secondary endpoints, such as quality-of-life measures and time to pulmonary exacerbation, the effect of Aeroquin was similar or superior to that of TIS. An open-label extension trial is ongoing.

Levofloxacin is a fluoroquinolone antibiotic with established safety and efficacy when administered orally or intravenously against numerous bacterial pathogens, including P. aeruginosa. According to the manufacturer, the use of a nebulizer allows the delivery of high concentrations of active drug directly to the site of infection in the lungs of CF patients in approximately 5 minutes while minimizing systemic exposure.

Source: Aptalis Pharma; January 7, 2013.

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