June 20, 2008
Aradigm Initiates Phase II Bronchiectasis Trial
Aradigm has started a multicenter Phase II clinical trial of its inhaled liposomal ciprofloxacin in adult patients with non-cystic fibrosis bronchiectasis.
Following an antibiotic washout period, 36 patients will be enrolled to receive daily inhaled liposomal ciprofloxacin for a period of 28 consecutive days.
The primary efficacy endpoint will be treatment of respiratory infection measured as the change in the density of Pseudomonas aeruginosa bacterial colony forming units in the sputum over the treatment period.
Secondary endpoints will include pulmonary function measurements and respiratory symptoms. The study is being conducted in bronchiectasis centers in the UK.
Igor Gonda, president and CEO of Aradigm, said: "Parallel Phase II clinical trials of liposomal ciprofloxacin in cystic fibrosis and non-CF bronchiectasis patients are enabling us to leverage the investment and expertise in this product for expansion of our pipeline of treatments of severe respiratory diseases."