The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product as measured by increases in FEV1.
A single center, open label, single dose study to demonstrate the pharmacodynamic bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate or albuterol sulfate/ipratropium in adult patients with COPD.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Advanced Respiratory and Sleep Medicine, PLLC
Hickory, North Carolina, United States
Primary Efficacy Endpoint: Change in FEV1
Change in FEV1
Time frame: Just prior to dosing and twenty minutes post dosing
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