Clinical Trials Resource Center


June 20, 2011

Aradigm reported results from a phase IIb trial of ARD-3100 (inhaled ciprofloxacin) for the treatment of non-cystic fibrosis bronchiectasis. This double-blind, placebo-controlled trial, ORBIT-1, enrolled 95 subjects who were randomized into four groups (3mL ARD-3100, 2mL ARD-3100 or matching placebo), and treated once-a-day for 28 days, followed by a 28 day off-treatment period. The primary endpoint, the mean change in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) from baseline to day 28, was reached. There was a significant mean reduction (p<0.001) of 2.942 log10 CFUs in the 3mL ARD-3100 group and a significant mean reduction (p<0.001) of 3.842 log10 CFUs in the 2mL ARD-3100 group compared to placebo. Pooled placebo groups had a mean reduction of log10 CFUs of 0.437. There was no statistically significant difference between the 2 mL and 3 mL ARD-3100 doses. Adverse events were similar between the treatment arms.

October 25, 2010

Aradigm released positive results from a phase IIb trial of ARD-3150, once-daily dual release inhaled ciprofloxacin, for the treatment of non-cystic fibrosis bronchiectasis. This randomized, double-blind, placebo-controlled trial, ORBIT-2, enrolled 42 adults in Australia and New Zealand. The subjects were treated once a day for 28 days with either ARD-3150 or placebo, followed by a 28-day off-treatment period. This on-off sequence was repeated three times. The primary endpoint, the mean change in Pseudomonas aeruginosa density in sputum from baseline to day 28, was reached with statistical significance over placebo. Data showed a significant mean reduction of 4.2 log10 units in the ARD-3150 group, reflecting an almost sixteen-thousand fold decrease in bacterial load, versus a mean reduction of 0.1 log10 units in the placebo group (p≡0.004). In addition, secondary endpoint analysis showed that 17 subjects in the placebo group required supplemental antibiotics for respiratory-related infections versus 8 subjects in the ARD-3150 group (p≡0.05). ARD-3150 was well tolerated.

January 26, 2009

Aradigm released positive results from a phase II trial of inhaled liposomal ciprofloxacin (ILCH) for the treatment of non-cystic fibrosis bronchiectasis. This open-label study enrolled 36 subjects in the United Kingdom. Following an antibiotic washout period, the subjects received either 3 mL or 6 mL of ILCH once-a-day for a four-week treatment period (28 consecutive days). The primary efficacy endpoint was 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. Both doses of ILCH in the evaluable population demonstrated significant mean decreases against baseline in the Pseudomonas Aeruginosa CFU over the 28-day treatment period of 3.5 log (p<0.001) and 4.0 log (p<0.001) units, respectively. ILCH was determined to be safe and well tolerated. 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). Based on the results, Aradigm plans to move forward with the development of inhaled liposomal ciprofloxacin.

September 3, 2007

Pharmaxis released positive results from a phase III trial of Bronchitol for the treatment of bronchietasis. This double-blind, placebo-controlled, parallel group study enrolled 362 subjects across Australia, New Zealand, United Kingdom, Northern Ireland. The subjects were randomized 2:1 to receive 320 mg of Bronchitol or placebo twice daily for 12 weeks. The trials primary endpoints, improvement in quality of life measures and mucus clearance versus placebo, were both achieved. At 12 weeks the subjects receiving Bronchitol showed a highly significant improvement in quality of life, as assessed by the St George Respiratory Questionnaire over placebo (p-value less than 0.05). In addition, mucous clearance at 12 weeks was also significantly improved over placebo (p-value less than 0.001). Treatment was well tolerated, with adverse events similar between the active and placebo groups. Pharmaxis filed a Special Protocol Assessment with the FDA for US phase III trial in August of 2007.

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