Boehringer Ingelheim Pharmaceuticals, Inc. today announced the publication of data that show Stiolto Respimat improved lung function across a range of measures (FEV1 AUC0–12, FEV1 AUC0–24, FEV1 AUC12–24, peak0-3 FEV1 and trough FEV1) compared to a European formulation of a combination of a long-acting beta agonist (LABA), salmeterol, and an inhaled corticosteroid (ICS), fluticasone propionate (50/500 mcg, 50/250 mcg).
Published online in Journal of Chronic Obstructive Pulmonary Disease (COPD), these data are from the ENERGITO® study, which investigated the impact of Stiolto Respimat on lung function among moderate to severe COPD patients.
“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, MD 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. “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.”
Long-acting beta2-adrenergic agonists, such as olodaterol, one of the active ingredients in Stiolto Respimat, increase the risk of asthma-related death. Stiolto Respimat is not indicated for asthma and should not be initiated in acutely deteriorating COPD patients or for the relief of acute symptoms. Stiolto Respimat is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. As with other inhaled medicines, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening. The most common adverse reactions were nasopharyngitis, cough and back pain.
Stiolto Respimat (www.STIOLTO.com) was approved in May 2015 for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.
Key findings include:
• In the six week Energito multicenter, randomized, double-blind, double-dummy, active-controlled, four-treatment, four-period, complete crossover study (NCT01969721), patients treated with once-daily Stiolto Respimat had significant increases in FEV1 AUC0-12, the primary endpoint, than patients treated with salmeterol/fluticasone propionate (T+O 5/5 mcg compared to salmeterol/fluticasone propionate 50/500 mcg: 129mL (95% CI: 107,150) p< 0.0001 and 50/250 mcg: 125mL (95% CI: 103,147) p<0.0001).
• In the study, FEV1 AUC0-24, the key secondary endpoint, was also significantly increased with Stiolto Respimat after six weeks compared to salmeterol/fluticasone propionate (T+O 5/5 mcg compared to salmeterol/fluticasone propionate 50/500 mcg: 86 mL (95% CI: 65,107) p< 0.0001 and 50/250 mcg: 82 mL (95% CI: 61,103) p< 0.0001).
• Stiolto Respimat also increased lung function compared to salmeterol/fluticasone propionate as measured by the following additional secondary endpoints at week six:
o FEV1 AUC12–24 (T+O 5/5 mcg compared to salmeterol/fluticasone propionate 50/500 mcg: 43 mL (95% CI: 21,65) p<0.0002 and 50/250 mcg: 39 mL (95% CI: 17,62) p<0.0007)
o Peak0-3 FEV1 (T+O 5/5 mcg compared to salmeterol/fluticasone propionate 50/500 mcg: 147 mL (95% CI: 123,171) p<0.0001 and 50/250 mcg: 142 mL (95% CI: 118, 166) p<0.0001)
o Trough FEV1 (T+O 5/5 mcg compared to salmeterol/fluticasone propionate 50/500 mcg: 58 mL (95% CI: 34,82) p<0.0001 and 50/250 mcg: 47 mL (95% CI: 22,71) p<0.0002)
The frequency of adverse events (AEs) was similar between all treatment groups with 29.7-37.0 percent of patients reporting at least one AE while on treatment. The most common adverse reactions were nasopharyngitis (common cold), COPD and cough.
“Boehringer Ingelheim has been committed to discovering and developing medicines for serious respiratory diseases for nearly a century. Part of this commitment is to help healthcare providers and people living with COPD better understand our medicines,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “The ENERGITO study further demonstrates the potential benefits of Stiolto Respimat for COPD patients.”
The Energito trial is part of the >15,000 patient Tovito Phase 3 clinical trial program investigating the efficacy and safety of Stiolto Respimat in COPD. The results build on the pivotal Phase III TONADO® trials that demonstrated STIOLTO RESPIMAT provides significant improvements in lung function (as measured by FEV1 AUC0-3hr and trough FEV1 response) compared to tiotropium RESPIMAT and olodaterol RESPIMAT across a broad range of disease severities including those with early stage disease (GOLD 2-4).
Source: Boehringer Ingelheim Pharmaceuticals
Filed Under: Drug Discovery