COPD Inhalation Therapy, Stiolto Respimat, Seen as Superior Treatment in Phase 3 Trial

Boehringer Ingelheim Pharmaceuticals, Inc., recently released data showing that Stiolto Respimat (inhalation spray) improved lung function over a range of measures in patients with chronic obstructive pulmonary disease (COPD), when compared to a European formulation of a long-acting beta agonist (salmeterol) and an inhaled corticosteroid (fluticasone propionate).

Stiolto Respimat was approved in 2015 for long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. It is counter-indicated as an asthma or acute COPD treatment.

The drug’s impact on lung function in COPD patients was investigated in a clinical trial called ENERGITO. Study observations were summarized in a report, “The lung function profile of once-daily tiotropium and olodaterol via Respimat® is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler® (ENERGITO® study),” published in the International Journal of Chronic Obstructive Pulmonary Disease.

“The publication of these results further demonstrates the ability of STIOLTO RESPIMAT to safely and effectively improve lung function in COPD patients,” James Donohue, a professor and former chief of the Division of Pulmonary & Critical Care Medicine at the University of North Carolina’s Chapel Hill School of Medicine, said 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.”

ENERGITO was a Phase 3, double-blind and randomized study in 229 people with moderate-to-severe COPD. Data found that the simultaneous application of tiotropium and olodaterol (Stiolto Respima) as a once-daily maintenance treatment resulted in superior lung function improvements compared to twice-daily salmeterol and fluticasone propionate treatment. In the six-week study, patients under Stiolto Respima therapy showed improved respiratory parameters, such as forced expiratory volume in 1 second (FEV1) up to 12 hours after therapy initiation — the trial’s primary endpoint — and up to 24 hours post-initiation — a secondary endpoint — relative to the baseline.

Stiolto Respima is not recommended to patients who are hypersensitive to tiotropium, ipratropium, olodaterol, or any component of the product.  The most common adverse reactions of the treatment are common cold, cough and back pain.

Chronic lower respiratory diseases, including COPD, are the third leading cause of death in the United States, estimated to affect about 15 million people. The most common symptoms of COPD are coughing, which can produce mucous fluid, and shortness of breath during physical activities.