SAN ANTONIO, Feb. 23, 2013 /PRNewswire/ -- Boehringer Ingelheim presented today a new subset of data from the Phase III UniTinA-asthma ™ program at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Antonio, Texas. In prespecified subgroups from two paired clinical trials, tiotropium delivered once daily via the Respimat® inhaler improved lung function and asthma control, as defined by a decrease in asthma exacerbations or worsening of asthma, in patients with poorly controlled asthma, irrespective of their allergic status. Patients included in the study remained symptomatic despite current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA).
"Patients with asthma may respond differently to treatment based on their allergic status, therefore it is important to investigate new therapies in both allergic and non-allergic patients," said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri. "The results of these trials show that tiotropium provides additional bronchodilation and reduces exacerbation rates in asthmatics who are uncontrolled on current therapy with at least ICS/LABA regardless of their allergic status, thus demonstrating its potential benefit for patients who need additional asthma control."
The two PrimoTinA-asthma ™ studies were replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV 1 less than 80 percent predicted and asthma control questionnaire score of greater than or equal to 1.5, while on at least high dose ICS/LABA. A total of 912 patients were randomized to receive tiotropium 5 mcg or placebo in addition to usual care for 48 weeks. In addition to ICS/LABA, patients in the trials were permitted to receive additional background therapy, 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 10 9/L, or CJ was "yes."
Peak FEV 1 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) FEV 1 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.