Boehringer Ingelheim's Tiotropium Improves Adolescent Asthma In Phase III Trial
By Cyndi Root
Boehringer Ingelheim announced in a press release a Phase III trial of tiotropium (brand name Spiriva) in adolescent asthma patients, showed statistically significant improvement in lung function. The company is presenting data from the trial program, UniTinA-asthma, at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany. Spiriva HandiHaler (tiotropium bromide inhalation powder) is Food and Drug Administration (FDA) approved for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) and for treatment of breathing problems associated with COPD.
Tunde Otulana, MD, SVP of Clinical Development and Medical Affairs at Boehringer Ingelheim, said, “We are encouraged by these latest data from the UniTinA-asthma program and they are an important addition to the growing data supporting the potential use of tiotropium in treating asthma patients across ages and severities.”
Tiotropium
Tiotropium is an antimuscarinic bronchodilator, opening air passages and easing symptoms of coughing and breathlessness. The long-acting formula allows patient administration once a day. Spiriva single-dose capsules are packaged in a blister card. They are inserted into the chamber in the HandiHaler. Pushing a button on the device breaks the capsule and releases the medicine.
RubaTinA-Asthma Study
The RubaTinA-Asthma study titled, “Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma,” was a Phase III trial of tiotropium 5 μg delivered via the Respimat inhaler. As measured by forced expiratory volume in one second (FEV1) response, adolescent tiotropium patients experienced improvement in lung function. The RubaTinA-Asthma program has enrolled 4,000 patients in more than 150 sites globally.
The Asthma Market
Recently, the EU approved Spiriva for adult asthma patients who are having breakthrough attacks despite treatment with inhaled corticosteroids (ICS) and long-acting beta agonists (LABAs). According to Boehringer, that approval makes Spiriva the first inhaled drug to be approved for asthma in over a decade. However, Datamonitor reports that, despite the fact the drug is establishing a new class of treatment, Spiriva’s sales will increase only slightly. The research company says that the total asthma market will reach $15 billion by 2021, with GlaxoSmithKline, AstraZeneca, and Teva leading the way. Generics are expected to erode the brand name market, with Singulair being the main victim, though Datamonitor also says that inhaled products will not see as much generic erosion as other medicines.