Monday, 21. June 2010

PARI LC SPRINT: nebuliser of choice for clinical trials with inhaled antibiotic

The main advantage of inhaled antibiotic therapy is that the drug directly reaches the site of action and reduces adverse events for the entire organism. Recent results from ongoing clinical trials with ciprofloxacin – an antibiotic with a broad antibacterial spectrum – were presented at the ATS conference in New Orleans. This drug is currently commercially available for oral or intravenous administration only, but is now being tested as an inhaled drug. The active substance has been specifically reformulated for patient-friendly use with once daily administration via the PARI LC SPRINT nebuliser.

According to the study investigators, the reason for selecting the  PARI LC® SPRINT nebuliser was that many patients with cystic fibrosis or bronchiectasis have similar systems at home and are very familiar with its use and inhalation technique.

The lungs of people suffering from cystic fibrosis or bronchiectasis are often persistently colonised with bacteria. This leads to an inflammatory process, mucus overproduction and severe tissue damage in this vital organ. Pseudomonas aeruginosa, a prevalent organism is of particular concern in this population, . Only certain antibiotics are suitable to destroy it -ciprofloxacin is one of them. It is a well-established drug available since the 1980’s which is currently available as tablets, drops, or solution for infusion or injection.

Inhaling this substance directly into the lungs may greatly increase the benefit to risk- ratio for patients – that is the firm belief of the scientists at Aradigm Corporation. The company specializes in products for severe lung disease. Researchers at Aradigm managed to pack ciprofloxacin into nanoparticles. This leads to a slow release of the active substance in the lungs and a concomitant long duration of action. The great advantage: the drug has to be administered only once daily. Cystic fibrosis patients will appreciate this, as their treatment burden is very high – often taking more than one hour per day.

The current state of development was presented during the annual conference of the American Thoracic Society (ATS). Study results so far, demonstrate that the number of bacteria in mucus that patients coughed up could be reduced by a factor of 1000 to 10000.  No serious adverse events occurred.

These encouraging results promote further development of the drug product and "will support inclusion of young CF patients in our future pivotal trials," said Dr. Paul Bruinenberg, the Company's Medical Director. In May, the FDA gave the “go-ahead” for further clinical studies.

Bilton et al. ATS conference 2010: poster E49
Bruinenberg et al. ATS conference 2010: poster E50