The FDA has approved a supplemental new drug application for Stiolto Respimat (tiotropium bromide/olodaterol inhalation spray, Boehringer Ingelheim) that adds data showing improvement in health-related quality of life among patients with chronic obstructive pulmonary disease (COPD) to the product labelling.
The new data, from the OTEMTO 1 and OTEMTO 2 clinical studies, show a clinically meaningful improvement in health-related quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ)––a disease-specific, patient-reported instrument that evaluates symptoms, activities, and the effect of the disease on daily life.
Stiolto Respimat inhalation spray is a combination of tiotropium, an anticholinergic, and olodaterol, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Long-acting beta2-adrenergic agonists, such as olodaterol, 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 hypersensitivity to tiotropium, ipratropium, olodaterol, or any of the product’s components. As with other inhaled medications, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening. The most common adverse events were nasopharyngitis, cough, and back pain.
Stiolto Respimat 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.
The new label expansion is based on data from two sets of phase 3 trials—OTEMTO 1 and 2, and TONADO 1 and 2—from the TOviTO clinical trial program for Stiolto Respimat, which includes more than 15,000 subjects with varying severities of COPD worldwide. OTEMTO 1 and 2 were 12-week placebo-controlled trials, and TONADO 1 and 2 were 52-week active-controlled trials, which together evaluated Stiolto Respimat in more than 6,700 COPD patients. Results from the OTEMTO 1 and 2 trials were published online in Respiratory Medicine.
Source: Boehringer Ingelheim; March 29, 2016.