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news.Aradigm has completed enrollment in its Phase II clinical trial of its inhaled liposomal ciprofloxacin in adult patients with non-cystic fibrosis bronchiectasis.
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The study was initiated in July 2008 in bronchiectasis centers in the UK and enrolled a total of 36 patients as planned. The subjects were randomized to two different dose levels of once-daily inhaled liposomal ciprofloxacin in a parallel design for a treatment period of 28 consecutive days.
The primary efficacy endpoint in the study is the change from baseline in the sputum Pseudomonas aeruginosa colony forming units over the treatment period, an objective measure of the reduction in pulmonary bacterial load. Additional endpoints will include pulmonary function measurements and respiratory symptoms.
Tunde Otulana, Aradigm’s chief medical officer, said: “We are pleased with the completion of enrollment of this study, an important milestone in the development of inhaled liposomal ciprofloxacin and would like to thank the clinical investigators for the on-schedule, rapid enrollment. We anticipate announcement of the data from the study in the first quarter of 2009.”