Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD (Advair and Quality of Sleep in COPD)
The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.
Chronic obstructive pulmonary disease (COPD) is a common and clinically important disease
characterized by chronic, irreversible airflow obstruction. Poor sleep quality and insomnia
are well described phenomena in patients with COPD. Several studies suggest sleep
disturbance adversely affects quality of life and may worsen daytime pulmonary function in
COPD patients. Improving sleep quality in patients with COPD, therefore, may not only
improve health quality, but also attenuate the decline in daytime pulmonary function.
Previous studies investigating the effects of inhaled bronchodilators on sleep quality in
COPD have shown conflicting results. These conflicting data prompted us to perform a
retrospective study on patients with COPD and co-existing sleep apnea (OSA) investigating
the effects of mechanical lung function impairment and lung hyperinflation on sleep. Our
study found a significant correlation between increased lung hyperinflation and reduced
sleep efficiency (a measure of sleep quality), and this relationship was preserved in a
multivariable regression model.
We hypothesize that Advair Diskus improves sleep quality by reducing lung hyperinflation in
COPD. To test this hypothesis, we propose a double-blinded, placebo controlled cross-over
study of Advair Diskus in patients with COPD and lung hyperinflation.
It was mutually decided by the sponsor and principal investigator to terminate the study
early due to study subject enrollment difficulties.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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