Bayer Healthcare has commenced a phase III trial investigating its drug-device combination ciprofloxacin dry powder for inhalation (DPI) in patients with chronic respiratory disorder non-cystic fibrosis bronchiectasis (NCFB).
The global study programme will investigate the clinical efficacy and safety of the product, which combines ciprofloxacin DPI 32.5 mg with rival the T-326 inhaler, produced by rival pharma company Novartis.
In addition, the ciprofloxacin DPI medicine was formulated using Novartis’ Pulmosphere technology, which can produce particles that are light and absorbent enough to be delivered deeply into the lung.
Bayer said the use of this technology means ciprofloxacin DPI particles can be produced at a small enough size to deliver “efficient and targeted antibacterial therapy”, while the delivery device is designed to make treatment patient-friendly.
The trial programme, named RESPIRE, will comprise two multi-national, randomised, placebo-controlled, double-blind, multi-centre studies.
Bayer will be particularly hoping ciprofloxacin DPI can show efficacy in the NCFB indication, for which there are currently no long-term treatment options specifically approved.
The disease involves a succession of recurrent microbial infections and persistent inflammation, which can lead to further damage of airway walls and increases the chances of further lung infections.
About 50 per cent to 80 per cent of cases are thought to have no known cause, according to Bayer.
“Within Bayer Healthcare we are committed to researching areas of high unmet need and conducting a large non-CF bronchiectasis programme illustrates this,” said Kemal Malik, head of global development at Bayer.
“We believe that ciprofloxacin DPI will make a difference to patients as it has the potential to reduce the number of exacerbations patients suffer from and improve their quality of life.”
Ciprofloxacin is already available in other formulations, such as tablet and oral liquid, and is marketed under the name Cipro to treat several types of bacterial infection.