LONDON & INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced the first results from the Phase III PHYSACTO® trial that shows Spiolto® (tiotropium+olodaterol) Respimat®, combined with exercise training, helps people with COPD walk for longer periods of time compared to those receiving placebo.1,2 All participants of the trial were enrolled in a self-management behaviour modification programme, which provided health education and skills to help them better manage their disease.1,2,5 These data were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.
After 8 weeks, in the tiotropium+olodaterol Respimat® combined with exercise training arm, exercise capacity in people with moderate to severe COPD significantly increased by 45.8 percent (p<0.001) compared to those receiving placebo with no exercise training (356 vs. 244 seconds respectively).2
“It is vital for people with COPD to stay active as this may help slow the progression of disease burden and reduce its impact on health,” said study investigator Professor Thierry Troosters, Head of the Research Group for Cardiovascular and Respiratory Rehabilitation, University of Leuven, Belgium. “This new study is the first to demonstrate that a holistic approach to COPD management, which includes behaviour modification enriched with exercise training and effective long-acting bronchodilator therapy, can improve exercise capacity, reduce shortness of breath and difficulty associated with daily activities.”
Additional PHYSACTO® results showed that even without exercise training, there was a significant improvement (29.2 percent; p<0.05) in exercise capacity in the tiotropium+olodaterol Respimat® arm compared to placebo (315 vs. 244 seconds respectively).2 Exercise capacity was measured by the length of time people with COPD could walk in an Endurance Shuttle Walking Test.2 This measures how far someone can walk at a standard speed without stopping for a rest.6 Furthermore, tiotropium+olodaterol Respimat® was shown to reduce shortness of breath (dyspnoea) associated with physical activity, compared to placebo.1
COPD is a serious but manageable lung disease, which is estimated to affect 210 million patients worldwide.7 Even in the early stages of COPD, people suffer from breathlessness during daily activities.4 To avoid shortness of breath, people with COPD often reduce the amount of physical activity they undertake and do less of their daily activities.4 This reduction in physical activities has a significant negative impact on their quality of life and can lead to their condition worsening.4
The PHYSACTO trial (NCT02085161) was designed to assess the effect of COPD maintenance therapy alone or in combination with supervised exercise training on exercise capacity and physical activity outcomes, including the amount of physical activity and perceived difficulties.1,2 The participants were randomised into groups, which received either tiotropium+olodaterol Respimat® with and without exercise training, or tiotropium Respimat® alone, or placebo.2 A 12-week self-management behaviour modification programme was included for all four groups to provide an optimal environment for translating improvements in exercise capacity into increases in daily activity.5 The self-management behaviour modification programme included strategies for participants to help them exercise – including a pedometer (a device to count steps) and education to support their COPD management plan.5
These new data build on results from the MORACTO® and TORRACTO® 1&2 studies that show tiotropium+olodaterol Respimat® significantly improves exercise endurance time vs. placebo.8,9 The PHYSACTO® trial is part of the large-scale TOviTO® Phase III clinical trial programme investigating the efficacy and safety of tiotropium+olodaterol Respimat® in COPD.
For ‘Notes to Editors’ and ‘References’ please visit: https://www.boehringer-ingelheim.com/press-release/New_Data:_Spiolto_Respimat_significantly_improves_exercise_capacity_in_people_with_COPD
