Thursday, 30. August 2012

PARI in clinical trials:

new-formulation of the antibiotic Ciprofloxacin prolongs the disease’s stable phase in patients with bronchiectasis

The lungs of non-CF bronchiectasis patients are often colonized with bacteria such as Pseudomonas aeruginosa and have to be treated with antibiotics. Bronchiectasis is a localized, irreversible dilation of part of the bronchial tree caused by destruction of the muscle and elastic tissue, which do not occur as a results of cystic fibrosis [CF].

A group of scientists from Australia together with the company Aradigm have successfully treated 42 non-CF bronchiectasis patients with nebulized new-formulation Ciprofloxacin (under development) in a multicenter, randomized, double blind and placebo-controlled study. The dosage was delivered once a day for 24 weeks (3 treatment cycles each consisting of 28 with and 28 days without the antibiotic) via a PARI LC SPRINT nebulizer. The study authors from Australia, New Zealand and the USA reported the following advantages of this therapy:

  • Rapidly developed and simultaneously prolonged duration of action thanks to the novel formulation 
  • Good tolerability
  • Highly significant reduction of the pathogen density in expectoration after only 28 days.
  • More than double stable phase of the disease (134 vs. 58 days) through the inhalation of new-formulation Ciprofloxacin with PARI LC SPRINT nebulizer.

Fig.: Inhalation of Ciprofloxacin with PARI LC SPRINT prolongs the stable phase of the disease from 58 to 134 days (p < 0.05).

Aradigm is going to continue their scientific project with new-formulation Ciprofloxacin (ARD-3150 – Pulmaquin™) due to the promising results and therefore plans to start the phase-III-study in Royal Brompton Hospital in London.

Source: Serisier DJ et al. 2011, ERS conference, oral presentation 1928