Effect of Aclidinium/Formoterol on Nighttime Lung Function and Morning Symptoms in Chronic Obstructive Pulmonary Disease
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
Summary
A number of studies have documented poor sleep quality and troublesome symptoms
(breathlessness, cough and sputum production) upon awakening in patients with COPD. However,
the investigators know very little about measurements of respiratory mechanics (i.e., lung
volumes, respiratory pressures, diaphragm function, etc) during sleep in these patients. The
investigators also know little about how modern bronchodilator therapies, or the timing of
when they are taken, affect respiratory mechanics during sleep or the severity of early
morning respiratory symptoms. COPD is often treated with inhaled bronchodilator medications
which are used to open up airways and make it easier for air to get in and out of the lungs.
The investigators are studying the effects of a new inhaler that contains two different types
of long-acting bronchodilator: formoterol [a long-acting beta2-agonist (LABA)] and aclidinium
bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]. Initial studies have
shown that this combination therapy taken twice daily can improve some lung function
measurements and respiratory symptoms in patients with moderate to severe COPD. There are
also reports that evening administration of this medication may provide important advantages
in patients with dominant nighttime and early morning symptoms. It is thought that sustained
bronchodilation and lung deflation during the night may improve respiratory mechanics,
diaphragmatic function, pulmonary gas exchange, sleep quality, and reduce severity of morning
symptoms. This study will be the first to explore the effects of a nighttime dose of
aclidinium/formoterol combination therapy on detailed measurements of respiratory mechanics
and early morning symptoms in COPD. This study will also give us a better understanding of
the mechanisms of early morning respiratory symptoms and their improvement with
bronchodilators.