Tobramycin inhalation solution a treatment option for non-cystic fibrosis bronchiectasis
In the BATTLE trial, patients with non-cystic fibrosis bronchiectasis assigned tobramycin inhalation solution once daily had a nonsignificant decrease in number of exacerbations compared with placebo.
“Tobramycin inhalation solution with other inhaled antibiotics are part of the standard care in cystic fibrosis and especially in patients with pseudomonas aeruginosa colonization,” Lotte C. Terpstra, PhD, of the department of pulmonology at Alkmaar Medical Center in the Netherlands, said during a presentation at the virtual European Respiratory Society International Congress. “In non-cystic fibrosis bronchiectasis, studies with inhaled antibiotics are limited. However, earlier findings also suggest a benefit.”
Researchers conducted BATTLE, a randomized, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of inhaled tobramycin solution (Pfizer) in 58 patients with confirmed non-cystic fibrosis bronchiectasis and at least two exacerbations in the past year and a positive sputum culture.
In the modified intention-to-treat population, patients were randomly assigned to tobramycin inhalation solution maintenance treatment (n = 26) or placebo (n = 26) for 1 year.
Primary endpoint was a 50% reduction in number of exacerbations on maintenance tobramycin compared with placebo. Secondary endpoints were time to first exacerbation, lung function change, quality of life, sputum density and safety.
Researchers observed a nonsignificant decrease in number of bronchiectasis exacerbations of 3.81 to 1.58 in patients treated with tobramycin compared with a decrease of 3.9 to 2.2 exacerbations for those treated with placebo (P = .147) with a 26% risk reduction for tobramycin inhalation solution.
Time to first bronchiectasis exacerbation was longer in the tobramycin group, with a mean of 29 weeks to first exacerbation compared with a mean of 21 weeks in the placebo group (HR = 0.64; 95% CI, 0.35-1.19).
“Although the primary endpoint was not significantly reached, this study showed that tobramycin inhalation solution once daily is a treatment option for bronchiectasis patients with frequent exacerbations infected by different pathogens,” the researchers concluded in their e-poster.
According to Terpstra, results from the other secondary endpoints of the BATTLE trial will be evaluated and presented later.