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Stiolto™ Respimat® Enters Market

By: Sylva Ohanian, Staff Writer

Chronic obstructive pulmonary disease (COPD) is a serious yet treatable lung disease, which affects 210 million people worldwide and is expected to be the third leading cause of death in the world by 2030.1 Symptoms, such as wheezing and coughing, can negatively impact breathing, especially during daily activities.1, 2 Acute exacerbation of symptoms is a hallmark of COPD that weakens quality of life and decreases overall health status. In order to prevent such exacerbations, treatment should be initiated as early as possible when patients are not in the end stage of the disease, during which disability is already substantial.3

In May of this year, the U.S. Food and Drug Administration (FDA) approved Stiolto™ Respimat® (Boehringer Ingelheim), a once-daily maintenance, oral inhalation spray for COPD.  It is indicated for the long-term treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. However, it is not approved for the treatment of acute deterioration of COPD or asthma.1, 4 In fact, a boxed warning on the label states that long-acting beta-agonists, such as olodaterol, increase the risk for asthma-related death and that the safety and efficacy of using Stiolto™ Respimat® in patients with asthma has not been established.4, 5

Stiolto™ Respimat® is the only COPD treatment that combines tiotropium and olodaterol.1 Both active ingredients are also marketed separately by Boehringer Ingelheim as maintenance treatments for COPD. Olodaterol, present in Striverdi® Respimat®, is a long-acting beta-2 agonist with a fast onset of action, improving airflow in less than five minutes of the first dose. On the other hand, tiotropium, available as Spiriva® Respimat® and Spiriva® Handihaler®, is a long-acting anticholinergic.1, 4, 5

Tiotropium-olodaterol approval was given mainly based on data from Phase III TONADOTM 1&2 trials, which studied 5,162 COPD patients.1, 5 Trials 1 and 2 were 52-week, replicate, randomized, double-blind, active-controlled, parallel group trials, which assessed Stiolto™ Respimat® (1029 patients) against tiotropium 5 mcg (1033 patients) and olodaterol 5 mcg (1038 patients). All products were administered once-daily in the morning via Respimat® inhaler. The primary endpoints of the trials included change from baseline in FEV1 AUC 0-3 hr and trough FEV1 after 24-weeks of treatment. Stiolto™ Respimat® established significant improvements with both primary endpoints as compared to olodaterol or tiotropium monotherapy.5

For the change from baseline in FEV1 AUC 0-3 hr endpoint, Stiolto™ Respimat® demonstrated a mean difference of 0.117 L (95% CI: 0.094 – 0.140) and 0.123L (95% CI: 0.100 – 0.146) from tiotropium 5 mcg and olodaterol 5 mcg in trial 1, respectively, as well as 0.103L (95% CI: 0.078 – 0.127) and 0.132L (95% CI: 0.108 – 0.157) from tiotropium 5 mcg and olodaterol 5 mcg in trial 2, respectively. Moreover, for the second primary endpoint of trough FEV1 after 24-weeks of treatment, Stiolto™ Respimat® established a mean difference of 0.071 L (95% CI: 0.047 – 0.094) and 0.082L (95% CI: 0.059 – 0.106) from tiotropium 5 mcg and olodaterol 5 mcg in trial 1, respectively, as well as 0.050L (95% CI: 0.024 – 0.075) and 0.088L (95% CI 0.063 – 0.113) from tiotropium 5 mcg and olodaterol 5 mcg in trial 2, respectively.5 The most common side effects reported during the trials were nasopharyngitis, cough, and back pain.4, 5

Although trials display impressive numbers and hopeful results, the true test of efficacy will come when Stiolto™ Respimat® is initiated in all patient populations for years to come. Nonetheless, with the addition of this new drug, physicians and healthcare professionals are given one more option in reaching an optimal treatment plan with their patients.


  1. FDA approves Boehringer Ingelheim’s Stiolto™* Respimat® as once-daily maintenance treatment for COPD. Boehringer Ingelheim. Available at: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/26_may_2015_copd.html. Published on 05/26/2015.
  2. Diagnosis of COPD. World Health Organization. http://www.who.int/respiratory/copd/diagnosis/en. Updated 2015.
  3. COPD management. World Health Organization. http://www.who.int/respiratory/copd/management/en. Updated 2015.
  4. Lowes R. FDA approves Stiolto Respimat for COPD. Medscape. http://www.medscape.com/viewarticle/845398. Published 05/26/15.
  5. Stiolto™ Respimat® (tiotropium bromide-olodaterol) [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; Revised 5/2015.

[pubmed_related keyword1=’tiotropium’ keyword2=’bromide’ keyword3=’olodaterol’]

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