Phase III studies show tiotropium delivered via Respimat inhaler proves effective in asthma patients

Boehringer Ingelheim today announced new data from large scale, Phase III studies showing that once-daily tiotropium delivered via the Respimat^® inhaler was effective and well tolerated in patients across asthma severities. These data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego.

"Even with current treatment options, at least 40 percent of patients with asthma remain symptomatic, which may put them at greater risk for exacerbations or asthma worsening" said Professor Pierluigi Paggiaro, Professor of Respiratory Medicine, University of Pisa, and lead author on the GraziaTinA-asthma^® study. "It is important to investigate the efficacy and safety of new treatment options across different asthma severities."

The first results from the Phase III GraziaTinA-asthma^® study were announced. The study demonstrated that tiotropium Respimat^® improved lung function and was well tolerated in patients with asthma who remain symptomatic while receiving low-dose maintenance ICS treatment.

Also presented at the meeting was a new subset of data from the Phase III MezzoTinA-asthma^® trials. The data showed that in patients with asthma who remained symptomatic while receiving moderate-dose maintenance ICS therapy, the addition of once-daily tiotropium reduced airflow obstruction independent of allergic status, as measured by the TH2 phenotype biomarker.

Finally, an analysis of a subset from the Phase III PrimoTinA-asthma^® trials found the addition of once-daily tiotropium improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA). This effect was demonstrated in patients with asthma who remained symptomatic despite receiving treatment with at least ICS/LABA. Previous results from these pivotal, PrimoTinA-asthma^® trials have shown that the addition of tiotropium Respimat^® significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening, compared with at least ICS/LABA therapy alone (current standard therapy).