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

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

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.