Boehringer Ingelheim has presented data from five Phase 3 trials of tiotropium Respimat for the treatment of asthma at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
The data come from two PrimoTinA-asthma trials (severe asthma), two MezzoTinA-asthma trials (moderate asthma), and a single GraziaTinA-asthma trial (mild asthma). According to the company, tiotropium Respimat produced improvement in lung function for all three severity levels of asthma in patients whose symptoms are not controlled by ICS therapy, whether the patients had allergies or not.
The five studies involved a total of 3,480 patients who received either 5 μg tiotropium, 2.5 μg tiotropium, or placebo plus ICS therapy with LABA or without LABA. In addition, patients were allowed to use other therapies, including various allergy treatments and Xolair.
BI’s Spiriva Respimat tioptropium SMI was approved by the FDA for the treatment of COPD in September 2014. The product has not been approved for the treatment of asthma.
Read the Boehringer Ingelheim press release.