Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Condition: COPD
MeSH terms: Disorders of Excessive Somnolence
Intervention: Advair 250; Placebo- matched; Placebo; Advair 250 - matched
Intervention description: 1 puff bid inhaled; 1 puff bid inhaled; Placebo 1 puff bid inhaled; i puff bid inhaled
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 45 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD; sleep; daytime somnolence

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with moderate to severe COPD as per GOLD criteria

          2. Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history

          3. Age 45 to 75 years, male or female

          4. FEV1 below 80% of predicted using CRAPO

          5. FEV1/FVC < 70% predicted

          6. Past or present tobacco smoker

          7. Female patients must be postmenopausal for 1 year or be willing to use birth control
             or abstain from sex.

        Exclusion Criteria:

          1. Asthma

          2. Use of oral or injectable corticosteroids within 2 months

          3. Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)

          4. Lung or heart disease except for COPD

          5. Deviated nasal septum, nasal polyps or anatomic obstruction of the nose

          6. Obesity defined as BMI >30kg/m2

          7. Inability to tolerate or history of allergy to long acting beta agonist or inhaled
             corticosteroid therapy.

          8. Inability to complete a 2 week run-in with albuterol prn as only therapy

          9. Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and
             other medications known to affect daytime somnolence or sleep quality

         10. Excessive use of alcohol or use of "recreational drugs"

         11. Use of narcotics, sleep aids, sedatives or sedating antihistamines.

         12. Night shift workers

         13. Women who are breast feeding or pregnant.