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Positive Phase III Results for Tiotropium in Asthma Patients
Data from two phase III studies have shown that tiotropium (Boehringer Ingelheim) — a long-acting inhaled anticholinergic bronchodilator delivered once daily with the Respimat inhaler — significantly improves lung function and reduces asthma exacerbations in patients who remain symptomatic despite treatment with at least inhaled corticosteroids and long-acting beta2-agonists (ICS/LABA). The new findings were presented at the 2013 American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting in San Antonio, Texas.
Tiotropium delivered with the Respimat inhaler is not licensed for the treatment of asthma and is not approved in the U.S.
The phase III PrimoTinA-asthma studies (1 and 2) were two double-blind parallel-group trials involving asthma patients with post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 80% predicted and an Asthma Control Questionnaire score of 1.5 or greater while on at least ICS/LABA. A total of 912 patients were randomly assigned to receive additional tiotropium 5 mcg (n = 256) or placebo (n = 256) for 48 weeks. In addition to ICS/LABA, patients in both studies were allowed to receive other background therapy, including antihistamines, anti-allergic agents, nasal steroids, and omalizumab.
In the overall study population, adding tiotropium provided significant improvements in lung function at 24 weeks, and these improvements were sustained over 48 weeks. In addition, patients who received tiotropium had a 21% risk reduction (hazard ratio = 0.79; P = 0.03) in the time to first severe exacerbation. Severe exacerbations were defined as requiring systemic corticosteroids for at least 3 days.
The addition of tiotropium also reduced the risk of any asthma exacerbation (defined by a significant increase in symptoms or by a decrease in peak expiratory flow [PEF] of more than 30% over more than 2 days) by 31% (P
In both studies, the improvements in lung function and reductions in exacerbations were achieved regardless of the patients’ allergic status.
Source: Boerhinger Ingelheim; February 23, 2013.