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Boehringer Ingelheim Presents Efficacy Data for Tiotropium in Symptomatic Asthma Patients in Relation to Allergic Status
Date:2/23/2013

herapy, including antihistamines, anti-allergic agents, nasal steroids and omalizumab. The subgroup of patients with potentially allergic asthma was identified using three criteria: total serum immunoglobulin E (IgE), blood eosinophilia, or clinician judgment (CJ). Allergic status was positive if serum IgE was greater than 430 mcg/L, blood eosinophilia was greater than 0.6 x 109/L, or CJ was "yes."

Peak FEV1 improved with tiotropium in Trial 1 irrespective of allergic status for IgE (P=0.86) and eosinophilia (P=0.46) and in Trial 2 for IgE (P=0.98), eosinophilia (P=0.18) and CJ (P=0.29). Predose (trough) FEV1 improved with tiotropium compared with placebo, irrespective of allergic status, across all criteria in Trial 1 (IgE, P=0.85; eosinophilia, P=0.83; and CJ, P=0.15) and Trial 2 (IgE, P=0.58; eosinophilia, P=0.38; and CJ, P=0.85). Pooled prespecified data analyses revealed that time to first severe asthma exacerbation and time to first asthma worsening were both increased with tiotropium compared with placebo, regardless of allergic status, based on the three criteria. In the overall study population, patients who received tiotropium had an improved time to first severe asthma exacerbation (risk reduction 21 percent; hazard ratio [HR] 0.79; P=0.03) and time to first asthma worsening (risk reduction 31 percent; HR 0.69; P<0.001), compared with patients receiving placebo.

Adverse events (AEs) were balanced between the allergic and non-allergic subgroups. The most frequently reported treatment-emergent AEs in both Phase III studies included asthma, peak expiratory flow (PEF) rate decrease and nasopharyngitis.  

"Through the UniTinA-Asthma™ program, our goal is to evaluate tiotropium in a wide range of asthma patients to determine where there may be a benefit," said Tunde Otulana ,
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SOURCE Boehringer Ingelheim
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