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The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD — AQuOS-COPD  

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)

Clinical Trial Summary

The purpose of this study is to determine if Advair Diskus improves sleep quality by reducing lung hyperinflation in COPD.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00741767
Study type Interventional
Source Northwestern University
Contact
Status Withdrawn
Phase N/A
Start date August 2008
Completion date February 2012
View Details
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