The objective of the study is to determine if a dual inhaled bronchodilator (Glycopyrrolate/Formoterol) is effective in increasing exercise time relative to placebo in patients with Chronic Obstructive Pulmonary Disease (COPD).
Enrolled patients with COPD will be randomized to receive either a dual bronchodilator (Glycopyrrolate/Formoterol) or placebo inhaler, and then crossed over to receive the opposite intervention. The study will consist of two treatment periods of two weeks, seperated by a washout period of two weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Exercise Tolerance
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Change in Exercise Time (Seconds) During Cycle Ergometer Exercise.
To determine the magnitude of exercise time improvement (seconds) with BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) relative to placebo during high intensity, constant work rate cycle ergometer exercise in COPD patients.
Time frame: 8-12 weeks
VD/VT as Determined by Transcutaneous CO2 Measurement (tcpCO2) During Constant Work Rate Cycle Ergometer Exercise.
To determine if the VD/VT can be reliably assessed during constant work rate exercise using transcutaneous CO2 measurement (tcpCO2) and, if so, if BEVESPI AEROSPHERE ® (Glycopyrrolate/Formeterol) results in a reduction in VD/VT relative to placebo at isotime during high intensity constant work rate exercise in COPD patients.
Time frame: 8 to 12 weeks
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