Oct 1999 Dura Pharmaceuticals, Inc. and Spiros Development Corporation II, Inc. announced that Dura, on behalf of Spiros Corp. II, has initiated the run-in period for the first in a series of pivotal clinical studies for Beclomethasone Spiros. The first clinical study is designed to determine safety and reliability of the Beclomethasone Spiros inhaler.
Patient dosing with beclomethasone is scheduled to begin next week.
Spiros is a new pulmonary drug delivery system in development designed to improve delivery of medication to the lung. Beclomethasone, currently marketed by other pharmaceutical companies as Vanceril and Beclovent, is a steroid drug prescribed as a maintenance therapy for the treatment of asthma. The goal of the Beclomethasone Spiros clinical program is to demonstrate the safety, efficacy and potential patient benefits of the Spiros system compared to a currently marketed form of beclomethasone delivered by metered dose inhaler. Dura's goal remains to initiate the clinical program for Albuterol Spiros by year-end 1999. The Spiros line of respiratory products is being developed by Dura, on behalf of Spiros Corp. II, as a novel means of delivering medication to the lung.