MONDAY, Sept. 20 (HealthDay News) -- The addition of the long-acting anticholinergic agent tiotropium bromide to an inhaled glucocorticoid is superior to a doubling of the dose of the glucocorticoid in improving lung function and symptoms in patients with uncontrolled asthma, and it is non-inferior to the addition of salmeterol, according to a study published online Sept. 19 in the New England Journal of Medicine to coincide with a presentation at the European Respiratory Society Annual Congress, held from Sept. 18 to 22 in Barcelona, Spain.
In a three-way, double-blind, triple-dummy crossover study, Stephen P. Peters, M.D., of Wake Forest University Health Sciences in Winston-Salem, N.C., and colleagues compared the addition of tiotropium bromide to an inhaled glucocorticoid with a doubling of the dose of the inhaled glucocorticoid or the addition of salmeterol among 210 patients with asthma.
Compared with a doubling of the dose of an inhaled glucocorticoid, the investigators found that the addition of tiotropium bromide resulted in a superior primary outcome, as measured by the morning peak expiratory flow (PEF), with a mean difference of 25.8 liters per minute. The addition of tiotropium bromide was also superior in most secondary outcomes, including evening PEF, the proportion of asthma-control days, daily symptom scores, and the forced expiratory volume in 1 second (FEV1) before bronchodilation. The addition of tiotropium bromide was also found to be non-inferior to the addition of salmeterol for all outcome measures and to increase the prebronchodilator FEV1 more than salmeterol.
"Since we could not examine either the rate of asthma exacerbations or long-term safety issues, our findings cannot be considered clinically directive. Additional studies that have sufficient statistical power to evaluate exacerbations and safety events are required to further establish the clinical efficacy of tiotropium. However, our data establish clinical equipoise to study larger cohorts of adults for longer periods of time with tiotropium as a therapy for asthma control," the authors conclude.
Boehringer Ingelheim provided the tiotropium and matching placebo for the study and had the opportunity to comment on the study design. Several authors disclosed financial ties to various pharmaceutical and/or medical device companies, including Boehringer Ingelheim.
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