Boehringer Ingelheim Pharmaceuticals announced the publication of promising new data regarding its inhalation spray, STIOLTO RESPIMAT, in the improvement of lung function when compared to therapy with an European formulation combining a long-acting beta agonist (LABA), salmeterol, and an inhaled corticosteroid (ICS), fluticasone propionate. The data comprising the results from the ENERGITO study have been published in the Journal of Chronic Obstructive Pulmonary Disease (COPD).
STIOLTO RESPIMAT, with active ingredients tiotropium bromide (anticholinergic agent) and olodaterol (LABA), was approved by the U.S. Food and Drug Administration (FDA) in May 2015 as a long-term once daily maintenance treatment in adult patients with COPD. Both active ingredients in its formulation work together to relax the muscles around the airways and prevent symptoms such as cough, chest tightness, and shortness of breath. The medication is not meant for asthma patients or for the relief of acute symptoms.
The ENERGITO study (NCT01969721), part of the TOviTO Phase 3 clinical trial program investigating the efficacy and safety of STIOLTO RESPIMAT in COPD, aimed to compare the lung function profile of moderate to severe COPD patients treated once-daily with STIOLTO RESPIMAT and the ones treated twice-daily with fluticasone propionate and salmeterol, delivered by the Accuhaler, for six weeks of treatment.
According to the results, patients treated once-daily with STIOLTO RESPIMAT had significant increases in lung function as assessed by a series of outcome measures (including FEV, forced expiratory volume), in comparison to patients receiving twice-a-day fluticasone propionate and salmeterol. Adverse events were similar between groups, and included nasopharyngitis (common cold), COPD, and cough.
“The publication of these results further demonstrates the ability of STIOLTO RESPIMAT to safely and effectively improve lung function in COPD patients,” said James Donohue, M.D., professor of medicine and former chief of the Division of Pulmonary & Critical Care Medicine at the University of North Carolina at Chapel Hill School of Medicine, in a press release. “These newly published data show a lung function improvement among COPD patients with STIOLTO RESPIMAT across a range of commonly used measures of lung function.”
Boehringer Ingelheim Pharmaceuticals, based in Ridgefield, Connecticut, is the largest U.S. subsidiary of Boehringer Ingelheim Corp., one of the world’s 20 leading pharmaceutical companies, with headquarters in Ingelheim, Germany.