Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Randomised, Open Label 2-Way Cross-over Study to Compare the Effects of Inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on Hyperinflation and Expiratory Flow Limitation in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).
This study will investigate the contributions of extra-fine glycopyrronium and formoterol
(within triple therapy) to improvements in small airway function in COPD patients. This will
be achieved by recruiting patients with hyperinflation, and measuring improvements in
hyperinflation and expiratory flow limitation as measurements of small airway disease.
This study will help understand the mechanisms of action of the bronchodilators within
BDP/FF/GB, and potentially encourage treatment of small airway disease in COPD with
extra-fine bronchodilator treatments. This trial will be conducted in compliance with the
Declaration of Helsinki (1964 and amendments) current Good Clinical Practices and all other
applicable laws and regulations.
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