TOBI Podhaler for suppression of infection in cystic fibrosis

Tobramycin is now available as a dry powder inhalation formulation (TOBI Podhaler). It is indicated for the suppressive therapy of chronic pulmonary infection due to P. aeruginosa in adults and children aged 6 years and older with cystic fibrosis.

The recommended dose is 112mg (four capsules) inhaled twice daily in alternating cycles of 28 days on treatment followed by 28 days off treatment.

Two controlled studies investigated the efficacy and safety of TOBI Podhaler; one study used TOBI nebuliser solution for comparison (n=553) and one study was placebo-controlled (n=95). Participants in both studies were aged 6 years and older with P. aeruginosa-infected cystic fibrosis and were treated twice daily with TOBI Podhaler over 3 cycles of treatment. The Podhaler formulation displayed similar tolerability and efficacy to nebulised tobramycin and significantly improved FEV₁ compared with placebo.

Cough was the most frequently reported adverse reaction in both clinical studies. In the active-controlled study, four patients in the Podhaler treatment group experienced a significant decrease in hearing, which was transient in 3 patients and persistent in 1 case.

Adverse events accounted for about half of the discontinuations with each formulation. Patients aged 20 years and older tended to discontinue more frequently with TOBI Podhaler than with the nebuliser solution (TOBI). In children under 13 years of age, discontinuations were more frequent in the TOBI nebuliser solution arm. Discontinuation rates with both formulations were similar in patients aged 13 to 19.