16 September 2015 - Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Spiriva Respimat (tiotropium bromide monohydrate) inhalation spray for use in the treatment of asthma. It is approved by the FDA for the 207070 Following previous regulatory approvals, tiotropium bromide monohydrate by soft-mist inhaler has been included in the recently updated Global Initiative for Asthma report (GINA) 2015 Global Strategy for Asthma Management and Prevention.

Almost one in two patients with asthma still experience symptoms while receiving maintenance therapy, putting them at increased risk of potentially life-threatening asthma exacerbations. Pivotal, Phase III study results show that Spiriva Respimat as an add-on treatment to ICS/LABA maintenance therapy:

• Significantly improves asthma symptoms - patients are 68% more likely to improve asthma control
• Significantly reduces the risk of patients having a severe asthma exacerbation by a fifth (21%) - reducing the number of patients who experienced a severe asthma exacerbation

The Phase III study results also showed that the safety of Spiriva Respimat is balanced as compared to placebo.

For more details, go to: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/16_september_2015_asthma.html