Gilead reports full data from CF drug trial

US biopharmaceutical company Gilead Sciences says that its inhaled antibiotic, aztreonam lysine, increased the time until further inhaled or intravenous antibiotic treatment was required by cystic fibrosis patients by an average of 21 days, compared with placebo. The conclusion is based on data from a Phase III study that was presented at this year's Cystic Fibrosis Therapeutics Development Network conference in Seattle.

The trial, known as AIR-CF2, was a randomized, double-blind, placebo controlled assessment, designed to examine the drug's safety and efficacy as a treatment for Pseudomonas aeruginosa-infected CF patients. Initially, the 211 study participants received a 28 day course of the antibiotic tobramycin to provide a working baseline, before being randomized to receive aztreonam lysine or placebo for a further 28 days. Those in the treatment group were provided with 75mg of the drug, administered either two or three times a day using the eFlow electronic nebulizer.

The results showed that, while the initial tobramycin treatment period brought about an average 1% improvement in forced expiratory volume, subsequent aztreonam lysine-based therapy improved FEV1 rating by 6.3% compared with placebo.