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news.Aradigm, a specialty pharmaceutical company, has announced positive top-line results from an open-label, four week treatment study of efficacy, safety and tolerability with its once daily inhaled liposomal ciprofloxacin hydrochloride in patients with non-cystic fibrosis bronchiectasis.
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The study was conducted at eight centers in the UK and enrolled a total of 36 patients. The patients were randomized into two equal size groups, one receiving 3ml of inhaled liposomal ciprofloxacin hydrochloride (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 (CFU), 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 Pseudomonas aeruginosa CFU over the 28-day treatment period of 3.5log (p<0.001) and 4log (p<0.001) units, respectively.
With regard to safety, there were no statistically significant changes in lung function at the end of treatment as measured by the normalized forced expiratory volume in one second (FEV1% predicted). ILCH was well tolerated; no bronchodilator use was mandated or needed before administration of the study drug, the company said.
Igor Gonda, president and CEO of Aradigm, said: We are very pleased with these data with our once-a-day inhaled liposomal ciprofloxacin hydrochloride in non-cystic fibrosis bronchiectasis patients. These latest results complement our previously reported successful Phase II study with ILCH in cystic fibrosis patients. We will continue to work with the regulatory authorities to complete the plans for the remaining development of ILCH.