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Aradigm Corporation (ARDM) has initiated a multicenter Phase 2 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 (CFU) in the sputum over the treatment period. Secondary endpoints will include pulmonary function measurements and respiratory symptoms. The study is being conducted in leading bronchiectasis centers in the United Kingdom.
Bronchiectasis is a chronic necrotizing infection of the bronchi and bronchioles that is associated with abnormal dilatation of the airways. It is frequently observed in patients with cystic fibrosis. However, it is a condition also affecting approximately 110,000 non-cystic fibrosis people in the United States, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage. There is currently no drug specifically approved for the treatment of this condition in the U.S. Aradigm has been granted orphan drug designation for the treatment of bronchiectasis with inhaled liposomal ciprofloxacin.
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