A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 microg / 5 microg; 5 microg / 5 microg) (Delivered by the Respimat Inhaler) Compared With the Individual Components (2.5 microg and 5 microg Tiotropium, 5 microg Olodaterol) (Delivered by the Respimat Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Trial Profile

A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 microg / 5 microg; 5 microg / 5 microg) (Delivered by the Respimat Inhaler) Compared With the Individual Components (2.5 microg and 5 microg Tiotropium, 5 microg Olodaterol) (Delivered by the Respimat Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2018

At a glance

  • Drugs Olodaterol/tiotropium bromide (Primary) ; Olodaterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TOnado 2
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 23 May 2018 Results (n=9,942) of a pooled safety analysis from NCT01431274, NCT01431287 and NCT02296138 studies presented at the 114th International Conference of the American Thoracic Society.
    • 16 Jan 2018 Results (n=5162) of post hoc analysis from two trial (NCT01431274 and NCT01431287) assessing lung function and patient-reported outcomes (PROs) in patients with moderate to very severe COPD receiving long-acting bronchodilator treatment over 1 year, were published in the Chest.
    • 24 May 2017 Results of a long-term safety analysis from renal impaired patients from NCT01431274 and NCT01431287 studies (n=3031) presented at the 113th International Conference of the American Thoracic Society
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