US-based pharmaceutical firm Aradigm has dosed first patient in the ORBIT-3 ('Once-daily Respiratory Bronchiectasis Inhalation Treatment') Phase III clinical trial of its proprietary formulation of inhaled ciprofloxacin (Pulmaquin) to treat non-cystic fibrosis bronchiectasis (non-CF BE).
Bronchiectasis is a severe, chronic and rare disease characterised by abnormal dilatation of the bronchi and bronchioles, frequently linked with chronic lung infections.
There are no drugs approved for the treatment of Non-CF BE, which represents an unmet medical need with high morbidity and mortality that affects more than 110,000 people in the US and approximately 200,000 people in Europe.
Nebraska Pulmonary Specialties respiratory physician Douglas Fiedler has dosed the first patient in the trial.
"I am very pleased to participate in this study to investigate the potential benefits of a new medication for my patients with a chronic debilitating respiratory disease for which we do not have any good evidenced-based treatments yet," Fiedler said.
Aradigm chief medical officer Juergen Froehlich said: "With our Phase III trials under way now, it is gratifying that many clinicians around the world will be joining our effort to find a treatment for an unmet medical need in patients with the severe condition of non-cystic fibrosis bronchiectasis."
The Phase III clinical programme includes of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be carried out in one of the trials.
A total of 255 patients will be enrolled in each trial and they will be assessed in a 48 week double blind period consisting of six cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin.
Superiority of Pulmaquin vs placebo during the double blind period will be assessed in terms of the time to first pulmonary exacerbation (primary endpoint).
Major secondary endpoints of the trial include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures.
The company said that lung function will be monitored as a safety indicator.
Aradigm president and CEO Igor Gonda said the initiation of the Phase III programme in non-CF BE is marking the accomplishment of a critical milestone for the company.
"We are grateful for the interest of patients with this disease to participate in this program, as well as for the support that we have been receiving from the COPD Foundation Bronchiectasis Consortium Registry," Gonda said.
Available in both oral and intravenous formulations, ciprofloxacin is a widely prescribed antibiotic and is used to treat acute lung infections.
It is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa.