Pulmonary function increased during sleep for patients with chronic obstructive pulmonary (COPD) receiving a triple-therapy regimen, but improvements to quality of life remain to be seen.
Pulmonary function during sleep improved in patients with chronic obstructive pulmonary disease (COPD) when they were administered a triple therapy regimen of budesonide, formoterol, and tiotropium compared with a placebo and tiotropium.
Although triple therapy has been shown to improve airway function, decrease COPD exacerbations, and improve quality of life, the study, published in Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, is the first to examine the effects of triple therapy on sleep quality in patients with COPD.
According to investigators, patients with COPD often complain about insomnia, difficulty falling asleep, nocturnal awakenings, daytime sleepiness, and impaired concentration during the day. Poor sleep quality characterized by increased sleep latency, decreased total sleep time, increased arousal index, and decreases in stage 3 sleep and rapid eye movement sleep is associated with poorer quality of life.
Additionally, research shows that disrupted sleep is a predictor for COPD exacerbations and overall survival. Study findings have suggested that certain medications may affect sleep in patients with COPD; however, results show that medications may improve, worsen, or have no effect on sleep.
The present randomized, placebo-controlled study incorporated a triple therapy of an inhaled corticosteroid (budesonide), a long-acting β-agonist (formoterol), and a long-acting anticholinergic (tiotropium). Twenty-five patients with stage 2 and 3 COPD in line with Gold Initiative for Chronic Obstructive Lung Disease criteria and who had bronchodilator regimens were recruited from the Pulmonary Clinic at Temple University Hospital in Philadelphia, Pennsylvania.
Twenty-three patients underwent and completed spirometry, polysomnography, an Epworth sleepiness scale (ESS), the Pittsburgh sleep quality index, the COPD-specific St. George’s Respiratory Questionnaire, and a Short Form 36 Health Survey Questionnaire, at baseline and after 28 days of treatment. Patients had a mean age of 55 years, and 48% were men.
After baseline data were collected, patients were randomized to receive either budesonide-formoterol 160 /4.5 mcg twice a day and tiotropium 18 mcg once a day (n = 10) or a placebo twice a day and tiotropium 18 mcg once a day (n = 13). The experimental group was slightly older and had a higher proportion of men compared with the control group.
At the end of the study period, the experimental group had a 29% increase in forced expiratory volume in 1 second (FEV1), from 0.75 to 1.00 L (P = .031). The placebo group had no significant change, from 1.20 to 1.15 L (P = .91).
A similar FEV1 improvement was observed in spirometry results for the experimental group but not for the placebo group:
This finding suggests that budesonide/formoterol/tiotropium therapy does not have a negative effect on measurements of quality of sleep, nocturnal oxygenation, or daytime function.
There were no significant changes in sleep efficiency, total sleep time, or quality of life observed in either group after 28 days.
Although their study time period was the similar to other studies evaluating the effects of inhaled bronchodilators in patients with COPD, the investigators noted that a longer period of time may be needed to demonstrate improvements in quality of life or sleep quality.
After 28 days, the control group had a significant increase in ESS scores, whereas the experimental group did not; however, the investigators noted that the baseline difference in ESS scores between the 2 groups may lessen the clinical significance of the increase observed in the placebo group.
The investigators noted their small patient cohort and short study period as limitations, and that gender differences between the groups may have affected some results.
Krachman SL, Vega ME, Yu D, et al. Effect of triple therapy with budesonide-formoterol-tiotropium versus placebo-tiotropium on sleep quality in patients with chronic obstructive pulmonary disease. Chronic Obstr Pulm Dis. Published online February 5, 2021. doi:10.15326/jcopdf.2020.0178