New Phase III data demonstrate tiotropium Respimat® improves lung function versus placebo and is well tolerated in asthma patients
Boehringer Ingelheim has announced new data from large scale, Phase III studies showing that once-daily tiotropium delivered via the Respimat® Soft Mist™ Inhaler improved lung function and was well tolerated in patients with varying degrees of asthma severity.1 These data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2014 annual meeting in San Diego.
The first results from the Phase III GraziaTinA-asthma® study demonstrated that tiotropium Respimat® 5 mcg and 2.5 mcg significantly improved lung function versus placebo (p<0.001) in asthma patients who remained symptomatic while receiving low-dose maintenance inhaled corticosteroid (ICS) treatment.1 Furthermore, tiotropium Respimat® was well tolerated; adverse events (AEs) were predominantly mild or moderate and were balanced between treatment arms.1
Commenting on the results, Dr Brian Lipworth, Professor of Pulmonology and Head of the Asthma and Allergy Research Group, Ninewells Hospital and Medical School, University of Dundee said, "Despite the many treatment options available, a large proportion of asthma patients remain symptomatic, meaning that that their condition is not well controlled. These trial results are encouraging - a new treatment option for asthma patients with varying degrees of severity would be welcomed by clinicians and patients alike."
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 Respimat® 5 mcg or 2.5 mcg improved both peak and trough FEV1 (forced expiratory volume in 1 second) versus placebo, independent of allergic status, as measured by the TH2 (T helper cells) phenotype biomarker.2
Finally, an analysis of a subset from the paired Phase III PrimoTinA-asthma® trials found the addition of once-daily tiotropium Respimat® 5 mcg improved lung function responses independently of concomitant use of a leukotriene receptor antagonist (LTRA). This effect was demonstrated in patients with severe asthma who remained symptomatic despite receiving treatment with at least ICS/ long-acting beta2-agonist (LABA).3 Previous results from these pivotal PrimoTinA-asthma® trials have shown that the addition of tiotropium Respimat® 5 mcg increased time to first severe asthma exacerbation (p=0.03), as well as time to first episode of asthma worsening (p<0.001), compared with at least ICS/LABA therapy alone (current standard therapy).4