Date: 2015-05-20
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Thoracic Society Congress 2015 in Denver
Company: Boehringer Ingelheim (Germany)
Product: tiotropium/olodaterol Respimat®
Action
mechanism: bronchodilatator/long-acting muscarinic antagonist/long-acting beta agonist.Tiotropium + olodaterol FDC is an investigational treatment that contains a long-acting muscarinic antagonist (LAMA) that provides bronchodilation by blocking M 3 muscarinic receptors (Spiriva®), combined with olodaterol (Striverdi®), a new once-daily and fast-acting LABA , delivered by the Respimat® Soft Mist™ Inhaler.
Disease: chronic obstructive pulmonary disease (COPD)
Therapeutic area: Inflammatory diseases - Pulmonary diseases - Respiratory diseases
Country: Argentina, Australia, Belgium, Bulgaria, Brazil, Canada, China,Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Hungary, India, Ireland, Italy, Japan, Republic of Korea, Mexico, The Netherlands, New Zealand, Norway, Portugal, Romania, Russian Federation, Serbia, Slovekia, Slovenia, South Africa, Spain, Sweden, Taiwan,Turkey, UK, USA
Trial
details: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).(NCT01431274) The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components (tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with COPD. (NCT01431287)
Latest
news: * On May 20, 2015, Boehringer Ingelheim announced new data analyses from the pivotal Phase III TONADO® 1&2 studies (NCT01431274/NCT01431287). Data showed tiotropium/olodaterol Respimat®‡ provided lung function benefit to patients with chronic obstructive pulmonary disease (COPD) right from the start of maintenance therapy, with the greatest benefit shown in the early stages of the disease. These data were presented at the American Thoracic Society Congress 2015 in Denver.The analyses showed: - Tiotropium/olodaterol Respimat® more than doubled the improvement in lung function* compared to Spiriva® (tiotropium) Respimat® in patients who had no prior maintenance bronchodilator therapy at baseline (148ml vs 72ml*)1 (abstract 64799) - Tiotropium/olodaterol Respimat® provided a significant improvement in lung function* compared to Spiriva® Respimat® in patients across all COPD stages with greatest improvements seen in patients in the early stages of COPD†2,3 (abstracts 64575 and 64845) A further new analysis from the TONADO® studies showed that almost 40% of patients with less severe COPD (GOLD A/B**) were taking ICS at the start of the trials (abstract 64710).14 These data are consistent with previous reports of the over- use of ICS-based therapies early in the management of COPD.15,16 GOLD guidelines recommend the use of ICS only in patients with more severe lung function impairment and at high risk of exacerbations (GOLD C/D). Irrespective of whether patients were taking ICS at the start of the trials††, data showed (abstract 64646) that tiotropium/olodaterol Respimat® significantly improved lung function‡‡ over Spiriva® Respimat® (133ml improvement in patients with ICS usage (p<0.001 vs. Tio 5μg) vs. 149ml in patients with no ICS usage (p<0.001 vs. Tio 5μg)).
- Tiotropium/olodaterol Respimat® had a comparable safety profile to Spiriva® Respimat® or Striverdi® (olodaterol) Respimat® alone5 (abstract 64778)
