New data from Boehringer Ingelheim's tiotropium Respimat Phase III UniTinA-asthma programme

Published on February 24, 2013 at 4:15 AM · No Comments

Tiotropium delivered once daily via Respimat™ significantly improved lung function and reduced asthma exacerbations in patients who remain symptomatic despite treatment with at least ICS/LABA, irrespective of their allergic status.

These were the main findings from a new subset of data from the Phase III UniTinA-asthma® programme presented for the first time today at the 2013 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in San Antonio, Texas.

"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 Dr. 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, demonstrating its potential benefit for patients who need additional asthma control."

The PrimoTinA-asthmaTM studies (1 and 2) were two replicate double-blind parallel-group trials including asthma patients with post-bronchodilator FEV1∆ <80% predicted and Asthma Control Questionnaire score ≥1.5 while on at least ICS/LABA. A total of 912 patients were randomised to additional tiotropium Respimat® 5 μg (n=256) or placebo (n=256) for 48 weeks.

"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. 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, demonstrating its potential benefit for patients who need additional asthma control."

Dr. Mark Vandewalker

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.

To investigate the relationship between response and the patients' allergic status, a pre-planned sub-group analysis of the data from both PrimoTinA-asthmaTM studies (1 and 2) was carried out.

The subgroup of patients with potentially allergic asthma was identified using three criteria: total serum immunoglobulin E (IgE), blood eosinophils, or clinician judgment. Allergic status was positive if serum IgE was greater than 430 μg/L, blood eosinophilia was greater than 0.6 × 109/L, or clinician judgement was "yes."

In the overall study population, adding tiotropium Respimat® provided significant lung function improvements at 24 weeks, which were sustained over 48 weeks. Also, patients who received tiotropium Respimat® had a 21% risk reduction (HR 0.79, P=0.03) in time to first severe exacerbation. Severe exacerbations were defined as requiring systemic corticosteroids for at least 3 days.

Furthermore, the addition of tiotropium Respimat® reduced the risk of any asthma exacerbation, defined by a significant increase in symptoms or peak expiratory flow (PEF) drop ≥30% over ≥2 days, by 31% (P<0.0001).

 

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