Pharmaceutical company Aradigm has announced the completion of patient enrollment for ORBIT-4, a clinical trial of Pulmaquin for non-cystic fibrosis bronchiectasis.
Patients have been enrolled in 16 countries, including the US, Canada, Australia, New Zealand, Israel, South Korea, Peru and countries throughout Europe. ORBIT-4 has recruited a total of 304 patients, and along with ORBIT-3, constitutes a global phase III trial to test the safety, efficacy and toxicity of the drug in a once-daily dose for those affected by non-cystic fibrosis bronchiectasis using identical study models, apart from a pharmacokinetic sub-study to be conducted in one of the two study groups.
Pulmaquin, a dual release formulation comprising of a mixture of liposomal, encapsulated and unencapsulated ciprofloxacin or a placebo, is to be inhaled once-daily for 6 cycles of 28 days alternating between 28 days off treatment throughout the total study period of 48 weeks. The treatment will be followed by a 28-day open label extension in which all participants are scheduled to receive Pulmaquin. The efficacy of the drug and its superiority against the placebo would be measured against the time taken for the first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations, including severe episodes and improvements in specific quality of life measures. Lung function is to be monitored as a safety indicator.