Tiotropium Improves Lung Function in Severe Asthma

Chicago—Asthma exacerbations are an important cause of asthma-related morbidity and mortality.

For patients with severe asthma, the use of tiotropium delivered via the Respimat® inhaler improved lung function and was well tolerated, according to data presented Tuesday at the CHEST 2013 meeting during session titled “Tiotropium and Asthma.” Tiotropium is currently being evaluated to determine the efficacy and safety in treating asthma patients and is not currently FDA approved for this indication.

The session featured 4 presentations from the tiotropium development program for adults with severe persistent asthma, including analysis from the PrimoTinA-Asthma phase 3 trials. The phase 3 studies were 2 replicate, double-blind, parallel group trials, which evaluated symptomatic adult patients with a confirmed diagnosis of severe asthma. Eligible patients had ≥5-year history of asthma diagnosed before age 40 and were either lifelong nonsmokers or ex-smokers (<10 pack-years) who quit smoking ≥1 year before study enrollment.

A total of 912 patients were randomized to receive tiotropium 5 mcg once daily delivered via the Respimat® inhaler (n=456) or placebo (n=456) for 48 weeks as add-on therapy to inhaled corticosteroid/long-acting beta agonists. The findings showed that the time to first exacerbation was 56 days longer with tiotropium versus placebo, corresponding to a 21% risk reduction (hazard ratio [HR], 0.79; P=0.03).

Furthermore, fewer patients in the tiotropium patients experienced ≥1 severe exacerbation compared with the placebo group (26.9% vs 32.8%, respectively). Tiotropium also reduced the risk of first asthma worsening (31%; HR, 0.69; P<0.001).

A pooled analysis of the adverse event (AE) data from the phase 3 trials was also presented. A lower incidence of AEs was reported in the tiotropium-treated group versus placebo (73.5% vs 80.3%). The most commonly reported AEs were asthma deterioration, reduced peak expiratory flow rate, and nasopharyngitis.

—Eileen Koutnik-Fotopoulos