Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Fluticasone (Advair), an inhaled corticosteroid and salmeterol, a long-acting beta agonist,
are approved for use in the management of COPD. Fluticasone/salmeterol has been shown to
significantly improve forced expiratory volume (FEV1) and decrease COPD symptoms (Calverley
et al. 2003, 2007). Inhaled corticosteroids have been shown to decrease frequency of COPD
exacerbations (Gartlehner et al. 2006) and long acting bronchodilators demonstrated a
reduction in dyspnea, increased airflow and reduction in hyperinflation in patients with
symptomatic COPD (Ramirez-Venegas et al. 1997). Specifically, salmeterol has also been shown
to have a positive effect on symptoms and health status of patients with COPD when added to
usual treatment (Stockley et al. 2006).
Previous research of subjects from our group with asthma has shown salmeterol to be
associated with sustained improvements in morning peak expiratory flow (PEF), protection from
nighttime lung function deterioration and improvement in patient perception of sleep (Wiegand
et al. 1999). This study has not been performed in patients with COPD nor has the effect of
salmeterol with fluticasone on sleep quality been assessed.
AIM: The aim of this study is to determine the effect of fluticasone/salmeterol on sleep
quality in patients with COPD and to compare efficacy of Advair 250 compared to placebo on
sleep.
The hypothesis is that there would be a significant improvement in sleep quality when
patients are placed on fluticasone/salmeterol as compared to placebo.
Phase:
Phase 4
Details
Lead Sponsor:
Milton S. Hershey Medical Center Penn State University
Collaborator:
GlaxoSmithKline
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Salmeterol Xinafoate Xhance