Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-blind, Cross-over Study to Evaluate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Compared With Tiotropium (5 µg), Both Delivered by the Respimat® Inhaler, on Breathlessness During the Three Minute Constant Speed Shuttle Test (3min CSST) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [OTIVATO TM]
The primary objective of the present study is to evaluate the effect of tiotropium +
olodaterol fixed dose combination (FDC) compared to tiotropium monotherapy on the intensity
of breathlessness during the 3min constant speed shuttle test (CSST).
A secondary objective is to explore the relationship between reductions in breathlessness
during the 3min CSST and reductions in breathlessness during activities of everyday living as
measured by the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ) following
bronchodilator therapy.
n/a
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