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5 Sep 2016

New Data: Stiolto Respimat inhalation spray significantly improved exercise capacity in people with COPD

Tiotropium+olodaterol Respimat along with exercise training and behavior modification significantly increased exercise capacity compared to placebo.

Boehringer Ingelheim has announced the first results from the Phase IIIb/IV PHYSACTO trial that showed Stiolto Respimat, combined with exercise training, helps people with chronic obstructive pulmonary disease (COPD) walk for longer periods of time compared with those receiving placebo. All participants of the trial were also enrolled in a self-management behaviour modification programme, which provided health education and skills to help better manage COPD. These data were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.

In the PHYSACTO trial, exercise capacity was measured by the length of time people with COPD could walk in an Endurance Shuttle Walking Test, which measures how far someone can walk at a standard speed without stopping for a rest.

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%, compared to those receiving placebo with no exercise training (356 vs. 244 seconds respectively). Furthermore, tiotropium+olodaterol Respimat was shown to reduce shortness of breath (dyspnea) associated with physical activity, compared to placebo.

Long-acting beta(2)-adrenergic agonists, such as olodaterol, one of the active ingredients in Stiolto Respimat, 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 a hypersensitivity to tiotropium, ipratropium, olodaterol, or any component of this product. As with other inhaled medicines, Stiolto Respimat may cause paradoxical bronchospasm that may be life-threatening. The most common adverse reactions were nasopharyngitis, cough and back pain.

"It is vital for people with COPD to stay active as this may help slow the progression of disease burden," said study investigator Professor Thierry Troosters, Head, 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 and reduce shortness of breath."

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