US-based pharmaceutical firm Aradigm has started dosing patients in the ORBIT-4 Phase III clinical trial of its proprietary formulation of inhaled ciprofloxacin (Pulmaquin) to treat non-cystic fibrosis bronchiectasis (non-CF BE).
The ORBIT-4 (‘Once-daily Respiratory Bronchiectasis Inhalation Treatment’) is the second of two Phase III clinical trials the company is carrying out with Pulmaquin in non-CF BE.
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The company said that dosing of the first patient in the ORBIT-3 clinical trial was carried out in April.
Institute of HealthCare Assessment respiratory physician Shari Brazinsky said: "A treatment that would cause a reduction in the frequency and severity of pulmonary exacerbations in this disease would be highly desirable."
The Phase III clinical programme for Pulmaquin in BE includes 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 evaluated 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 they will be given Pulmaquin.
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By GlobalDataSuperiority of Pulmaquin vs placebo during the double-blind period is being assessed in terms of the time to first pulmonary exacerbation (primary endpoint).
Key secondary endpoints of the trial include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures.
Aradigm chief medical officer Juergen Froehlich said: "The QIDP Designation will provide us with the opportunity for expedited regulatory interactions to make a potential new treatment for non-cystic fibrosis bronchiectasis more expeditiously available to many patients with this severe condition."
