Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Condition: COPD
MeSH terms: Disorders of Excessive Somnolence
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Advair 250; Placebo- matched; Placebo; Advair 250 - matched
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 puff bid inhaled; 1 puff bid inhaled; Placebo 1 puff bid inhaled; i puff bid inhaled
Other intervention name(s): fluticasone/salmeterol 250/50; fluticasone/salmeterol 250/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COPD; sleep; daytime somnolence