Aradigm drug reduces pulmonary bacteria

Emerging US specialty drug firm Aradigm has reported positive top-line results from an open-label, four-week treatment study of efficacy,  safety and tolerability with its once-daily inhaled liposomal  ciprofloxacin HCl in patients with non-cystic fibrosis bronchiectasis.

The study was conducted at eight centers in the UK and enrolled a total  of 36 patients, who were randomized into two equal size groups, one 3mL  of ILCH and the other receiving 6mL of ILCH, once-a-day for the  four-week treatment period.

The primary efficacy endpoint was the change from baseline in the sputum  Pseudomonas aeruginosa colony forming units, the standard objective  measure of the reduction in pulmonary bacterial load. The 3mL and 6mL  doses of ILCH in the evaluable patient population demonstrated  significant mean decreases against baseline in the P. aeruginosa CFU  over the 28-day treatment period of 3.5 log (p<0.001) and 4.0 log  (p<0.001) units, respectively.