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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The company said that dosing of the first patient in the ORBIT-3 clinical trial was carried out in April.

"A treatment that would cause a reduction in the frequency and severity of pulmonary exacerbations in this disease would be highly desirable."

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Superiority 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."