Aradigm Corporation, an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases recently announced that the company has completed the enrollment of patients in the ORBIT-4 Phase III pivotal study of Pulmaquin®, the company’s investigational formulation of inhaled ciprofloxacin, for non-cystic fibrosis bronchiectasis patients (non-CF BE) who are infected with Pseudomonas aeruginosa.
ORBIT-3 and ORBIT-4 are two Phase III pivotal trials that the company is conducting with Pulmaquin in this specific patient population. The studies are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials.
The ORBIT-4 clinical trial is a multi-center, placebo-controlled, double-blind pivotal clinical trial that is being conducted worldwide and that it has enrolled a total of 304 patients across 16 countries. These include Australia, Israel, South Korea, Peru, New Zealand, Canada, United States and European countries.
“The completion of enrollment in the first of our Phase III clinical trials is a major milestone in the development of our investigational formulation Pulmaquin. We sincerely thank our investigators and the patients with non-CF BE for participating in this important clinical trial which aims to decrease the substantial disease burden due to chronic lung infections with P. aeruginosa by reducing their frequency and improving the quality of life of these patients,” said Juergen Froehlich, MD, Chief Medical Officer of Aradigm.
For each of the trials, the dose regimen involves 48 weeks of double blind treatment of 6 cycles of 28 days on treatment/28 days off treatment with Pulmaquin or placebo. This is then followed by a 28-day open label extension period where all patients will be treated with Pulmaquin.
During the double-blind period, the superiority of Pulmaquin vs. placebo will be investigated with the assessment of the time to first pulmonary exacerbation. The study’s secondary endpoints are the reduction in the number of pulmonary exacerbations, and the improvements in quality of life. Lung function is being monitored as a safety indicator.
Non-Cystic Fibrosis Bronchiectasis (BE) is a chronic “orphan” condition characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic infection. The patient’s lung function is often irreversibly reduced compared to that found in healthy individuals. BE is frequently observed in patients with cystic fibrosis (CF). However, it is a condition that affects over 110,000 people without CF in the United States and many more in other countries, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage.
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