Status:
COMPLETED
Comparing Fluticasone-salmeterol in Chronic Obstructive Pulmonary Disease (COPD) and Sleep
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
COPD
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief 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 impro...
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 w...
Eligibility Criteria
Inclusion
- Patients with moderate to severe COPD as per GOLD criteria
- Insomnia, poor sleep, non-restorative sleep or daytime sleepiness by history
- Age 45 to 75 years, male or female
- FEV1 below 80% of predicted using CRAPO
- FEV1/FVC \< 70% predicted
- Past or present tobacco smoker
- Female patients must be postmenopausal for 1 year or be willing to use birth control or abstain from sex.
Exclusion
- Asthma
- Use of oral or injectable corticosteroids within 2 months
- Previous diagnosis of sleep disorder breathing (sleep apnea, narcolepsy, etc.)
- Lung or heart disease except for COPD
- Deviated nasal septum, nasal polyps or anatomic obstruction of the nose
- Obesity defined as BMI \>30kg/m2
- Inability to tolerate or history of allergy to long acting beta agonist or inhaled corticosteroid therapy.
- Inability to complete a 2 week run-in with albuterol prn as only therapy
- Use of narcotics, sleep aids, sedating antihistamines, sedatives, MAO Inhibitors, and other medications known to affect daytime somnolence or sleep quality
- Excessive use of alcohol or use of "recreational drugs"
- Use of narcotics, sleep aids, sedatives or sedating antihistamines.
- Night shift workers
- Women who are breast feeding or pregnant.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00731770
Start Date
January 1 2009
End Date
April 1 2010
Last Update
March 29 2019
Active Locations (1)
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1
Penn State Universuty
Hershey, Pennsylvania, United States, 17033