NCT00731770

Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep

TITLE: Double-blinded, Double-dummy, Study Comparing Fluticasone-salmeterol to Placebo in Patients With COPD and Associated Poor Sleep or Daytime Somnolence.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

RATIONALE: Chronic obstructive pulmonary disease (COPD) is a term that describes a disease state in which there is chronic irreversible airflow limitation. It has been well documented that patients with COPD have disturbed sleep. Certain published reports suggest that more than 50% of COPD patients have sleep complaints (George et al., Drugs, 2003). These patients are found to have sleep onset latency and poor sleep maintenance. While their sleep disturbance may be explained in part by side effects of medications, it could also be a result of nocturnal gas exchange abnormalities (Knutty 2004). In COPD there is worsening hypoxemia and hypercapnia during sleep, particularly rapid eye movement (REM) sleep, and sleep disturbance seems to be worse with more severe COPD. It is commonly believed that optimizing medical management of the disease is important in improving the sleep quality of these patients and thus leading to improved quality of life. Fluticasone, 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 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 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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Advair 250	1 puff bid inhaled
DRUG	Placebo- matched	1 puff bid inhaled
DRUG	Placebo	Placebo 1 puff bid inhaled
DRUG	Advair 250 - matched	i puff bid inhaled

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-08-11
• Last updated: 2019-03-29
• Results posted: 2019-03-29

Locations

1 site across 1 country: United States