A recent study showed that Tiotropium used as a supplementary therapy to inhaled corticosteroids (ICS) reduced airflow obstruction and improved asthma control in patients with moderate asthma. The study entitled “Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomized trials” was published in The Lancet Respiratory Medicine by Dr. Huib A M Kerstjens from the University of Groningen, University Medical Center Groningen, Department of Pulmonary Medicine and Tuberculosis, and Groningen Research Institute for Asthma and COPD, Groningen, Netherlands, and further colleagues.
The research team performed two 24-week, replicate, randomized, double blind, placebo-controlled trials (NCT01172808 and NCT01172821) to evaluate the safety and efficacy of tiotropium in patients with moderate asthma with symptoms under treatment with inhaled corticosteroids (ICS) (400 µg to 800 µg budesonide). These trials were done at 233 centers in 14 countries, including the United States, between August 2010 and November 2012. For this, 2,103 patients were enrolled with patients being randomly assigned to be treated once a day with tiotropium 5 µg, 2.5 µg, and twice a day with salmeterol 50 µg or placebo. The tiotropium and salmeterol are, respectively, a long-acting, 24-hour, anti-cholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and long-acting beta2-adrenergic receptor agonist drug (LABA) used to maintain and prevent symptoms of asthma and maintain COPD symptoms.
In these trials the co-primary endpoints, evaluated at week 24, were the difference in peak forced expiratory volume in 1 second (FEV1) response, measured within the first 3 h after the last dosing of the day and responder rate addressed by the seven-question Asthma Control Questionnaire (ACQ-7). Serious adverse effects were observed in 2% of cases and were similar across all groups.
“Our findings show that in patients with moderate asthma who are receiving medium-dose inhaled corticosteroids, addition of once-daily tiotropium significantly improves lung function and asthma control compared with placebo, and has similar efficacy and tolerability to salmeterol,” wrote Dr. Huib A.M. Kerstjens and colleagues.
The researchers found that a dose of tiotropium given as a once a day add-on to medium-dose inhaled corticosteroids is an effective controller therapy for patients with moderate asthma with an uncontrolled disease when treated only with inhaled corticosteroids. The profiles of response with tiotropium or salmeterol doses were similar and both had good safety and tolerability. Tiotropium is a safe and effective bronchodilator and an alternative drug to salmeterol in this patient population.
“These findings potentially support the addition of a long-acting anti-cholinergic to inhaled corticosteroids in patients with moderate asthma,” said the researchers in the news release.