Phase III Success for Boehringer Ingelheim Asthma Drug
Boehringer Ingelheim said today its once-daily asthma drug tiotropium, delivered via Respimat® Soft Mist™ Inhaler, producedfavorable Phase III results by increasing the time to first severe exacerbation, and time to first episode of asthma worsening across a broad spectrum of symptomatic patients receiving standard care treatments.
Those increases were in comparison to placebo in asthma patients receiving standard care of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA) therapy, and were independent of age, allergic status, smoking status, and bronchodilator response, BI said.
BI presented preliminary results based on preplanned subgroup analyses of data from the PrimoTinA-asthma™ Phase III studies at the American Thoracic Society Congress in Philadelphia.
"These results are extremely encouraging as we continue to investigate tiotropium as a potential treatment for asthma," Richard Russell, Ph.D., FRCP, consultant chest physician at the U.K.’s Wexham Park Hospital, and a U.K.-based investigator in PrimoTinA-asthma. "There remains a significant number of asthma patients who continue to be symptomatic despite available therapeutic options. The results suggest tiotropium may be an efficacious treatment option for patients."
During BI’s presentation, Professor David Halpin, D.Phil., consultant in respiratory medicine at the U.K.’s Royal Devon and Exeter Hospital, said patients enrolled in PrimoTinA-asthma were reasonably certain to have had asthma and not COPD, based on age of onset, duration of symptoms, smoking status, allergic status, and bronchodilator response. Tiotropium has been shown effective in COPD patients with concomitant features of asthma.
PrimoTinA-asthma consisted of two parallel-group trials including asthma patients ages 18 to 75, with a five-plus-year history of asthma diagnosed before age 40; and life-long nonsmokers or ex-smokers who consumed less than one pack of cigarettes daily for 10 years, then quit smoking one or more years before study enrollment.
Over 48 weeks, 456 patients were randomized to tiotropium Respimat, while an equal number received placebo. Patients were allowed additional background therapy including theophylline, anti-allergic agents, stable systemic steroids, and omalizumab.